Pfizer
Nervous system symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | tingling, dizziness, tremor |
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC...
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CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
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| 40 | 2020-12-31 | pain, pain in extremity |
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, ache...
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No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
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| 40 | 2021-01-01 | feeling hot |
Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved...
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Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.
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| 40 | 2021-01-01 | pain in extremity |
Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Sev...
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Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.
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| 40 | 2021-01-03 | dizziness |
Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ...
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Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.
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| 40 | 2021-01-03 | dizziness, unresponsive to stimuli |
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug...
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Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
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| 40 | 2021-01-03 | pain | Extreme swelling and erythema at vaccination site, mild pain, multiple episodes of diarrhea. |
| 40 | 2021-01-03 | dizziness |
Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneo...
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Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
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| 40 | 2021-01-03 | tremor, seizure, weakness, lightheadedness |
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shak...
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I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
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| 40 | 2021-01-03 | numbness |
On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of d...
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On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity. It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.
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| 40 | 2021-01-03 | pain in extremity |
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted...
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Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.
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| 40 | 2021-01-03 | numbness, tingling |
Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal a...
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Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal area of scalp within 30 min of vaccine that persisted x 90 min. Also reported transient "numbness" of R anterior thigh that resolved spontaneously after 30 min. No pruritic, urticaria, rash. No mucus membrane symptoms - no conjunctivitis, rhinitis or oral/perioral symptoms. No mucosal swelling or sense of swelling. No respiratory symptoms. No presyncopal symptoms. Vitals: BP 134/87, Pulse 103, sats 100%.
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| 40 | 2021-01-03 | numbness, pain in extremity |
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. ...
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Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
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| 40 | 2021-01-03 | pain | local- soreness systemic/local-urticaria |
| 40 | 2021-01-04 | pain |
12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm...
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12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.
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| 40 | 2021-01-04 | tingling, numbness |
About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek...
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About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek were numb). I also had some numbness on the top of my thigh. I sat for monitoring for a couple hours and was sent home. The tingling moved to the back of my head for a little while last night and seemed to had resolved before I went to bed around 10p. The tingling seems very minimal this morning...on a scale of 1-10, 10 being the most noticeable, yesterday was a 10. Today seems to be a 1 or 2. Only noticeable if I am sitting still and be more along my ear and not my head or shoulder. There is still the weird feeling (similar to numbness) in my face and my thigh. My face is getting better.
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| 40 | 2021-01-04 | feeling hot, dizziness |
About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense...
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About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.
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| 40 | 2021-01-04 | pain | Fever, body aches, chills and sweats |
| 40 | 2021-01-04 | dizziness |
Following vaccination, patient reported throat scratchiness in the right side. She has had previous ...
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Following vaccination, patient reported throat scratchiness in the right side. She has had previous allergic reactions to allergy shot and stated that this is how she felt before. VS: 0740- HR 127, O2 100%, BP 127/75. 0752- HR 100, O2 100%, BP 134/82. 0805- HR 103,O2 100%, BP 159/80. Patient evaluated by physician and monitored in clinic for additional 30 minutes. 0841 HR 104 O2 98 BP 135/77; 0847 HR 100 O2 100 BP 136/73. Discharged from clinic. On 1/4/21 patient presented to urgent care reporting that over the course of the evening and next day she developed intermittent fevers with a T-max of 103 degrees as well as headache and lightheadedness. She has had intermittent symptoms ongoing since her vaccination prompting her to come for evaluation at urgent care. She denies difficulty swallowing. She had been intermittently taking antihistamines. Positive for sore throat. COVID antigen testing was negative, patient discharged.
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| 40 | 2021-01-04 | numbness |
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ...
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Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
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| 40 | 2021-01-04 | tingling, numbness |
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h...
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Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 40 | 2021-01-04 | pain, migraine, weakness |
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s...
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One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
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| 40 | 2021-01-04 | pain |
Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills ...
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Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.
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| 40 | 2021-01-04 | dizziness | Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea |
| 40 | 2021-01-04 | numbness | She describes joint pain and gradual numbness on her arms. |
| 40 | 2021-01-04 | numbness, tingling |
numbness and tingling in all four extremities; numbness and tingling in all four extremities; interm...
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numbness and tingling in all four extremities; numbness and tingling in all four extremities; intermittent weakness in my hands, arms and legs; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0140), via an unspecified route of administration on the left arm on 18Dec2020 12:30 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history reported as none and the patient had no known allergies. The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 13:30, the patient was experiencing numbness and tingling in all four extremities after the first dose of the vaccine. The patient also experienced intermittent weakness in hands, arms and legs. It was also mentioned that the patient had numbness and tingling in all four extremities for the past 10 days. The patient did not receive any treatment for the events. Outcome of the events were unknown.
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| 40 | 2021-01-05 | tingling, dizziness |
After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling...
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After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.
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| 40 | 2021-01-05 | pain in extremity | Arm soreness, mild fatigue but she is overall okay |
| 40 | 2021-01-05 | pain, feeling cold |
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t...
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Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
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| 40 | 2021-01-05 | pain in extremity | Fevers started 12 hours post vaccine. Severe arm pain. Out of proportion to previous IM vaccines. |
| 40 | 2021-01-05 | pain in extremity, pain |
Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and de...
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Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and developed a fever of 101.
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| 40 | 2021-01-05 | tingling, weakness, dizziness, vertigo | Lightheadedness, dizziness - "felt like the room is spinning," weakness and tingling all extremities |
| 40 | 2021-01-05 | difficulty speaking |
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R...
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Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
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| 40 | 2021-01-05 | dizziness |
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d...
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Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
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| 40 | 2021-01-05 | pain in extremity |
Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day o...
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Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.
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| 40 | 2021-01-05 | tingling |
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,...
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Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
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| 40 | 2021-01-05 | pain in extremity |
Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the ...
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Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Recommendation? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.
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| 40 | 2021-01-05 | tingling | Tingling in fingers Fingers contracting without pain, only tingling |
| 40 | 2021-01-05 | pain in extremity |
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and starte...
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Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
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| 40 | 2021-01-05 | feeling hot |
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea...
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Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
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| 40 | 2021-01-05 | weakness |
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ...
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Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
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| 40 | 2021-01-05 | pain in extremity |
Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep wa...
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Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep was very sore. I have regular yearly flu shots with no issues.
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| 40 | 2021-01-05 | pain in extremity |
a red area at the injection site /growing red spot at injection site; raised area at the injection s...
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a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated "thought I got bit by something" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.
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| 40 | 2021-01-05 | pain in extremity |
approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was p...
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approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.
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| 40 | 2021-01-05 | dizziness |
dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; diz...
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dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
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| 40 | 2021-01-05 | pain in extremity, feeling hot |
left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable ...
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left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.
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| 40 | 2021-01-06 | tingling, pain, pain in extremity |
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash...
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After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
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| 40 | 2021-01-06 | pain | Body aches. Stayed home from work |
| 40 | 2021-01-06 | pain |
Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had co...
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Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.
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| 40 | 2021-01-06 | weakness, pain | HEADACHE FEVER CHILLS NAUSEA VOMITING WEAKNESS BODY ACHE |
| 40 | 2021-01-06 | pain, weakness |
Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and...
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Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and muscle aches. Took 600mg ibuprofen. At 1am had massive headache body aches chills to the core. Took more Tylenol. At 5:30am fever of 100.4 and flu like symptoms. Called into work.
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| 40 | 2021-01-06 | pain, weakness | Headache, chills, body-ache, fever, nausea, vomiting, and weakness. |
| 40 | 2021-01-06 | pain |
I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a s...
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I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.
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| 40 | 2021-01-06 | pain in extremity |
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really cou...
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I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.
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| 40 | 2021-01-06 | pain |
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was j...
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Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
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| 40 | 2021-01-06 | pain, pain in extremity |
On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful...
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On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone
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| 40 | 2021-01-06 | pain |
Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately ...
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Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.
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| 40 | 2021-01-06 | pain in extremity, tingling |
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i...
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Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
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| 40 | 2021-01-06 | pain | rash on arms and torso; shortness of breath, and body aches |
| 40 | 2021-01-07 | tremor |
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra...
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After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
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| 40 | 2021-01-07 | dizziness |
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread...
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Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
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| 40 | 2021-01-07 | dizziness |
At about 10 minutes after administration, patient felt a bit lightheaded. She was given apple juice ...
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At about 10 minutes after administration, patient felt a bit lightheaded. She was given apple juice and was able to bring her mask down from her face and lightheaded feeling quickly resolved. BP 148/83 p 74.
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| 40 | 2021-01-07 | tingling, dizziness | Dizziness Tingling Left arm to finger tips. |
| 40 | 2021-01-07 | pain in extremity, dizziness |
Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a conta...
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Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
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| 40 | 2021-01-07 | pain |
Fatigue; fever; chills; body aches; headache; This is spontaneous report from a contactable other hc...
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Fatigue; fever; chills; body aches; headache; This is spontaneous report from a contactable other hcp (patient). A 40-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 29Dec2020 11:45 at single dose for COVID-19 immunization. Medical history included anxiety/depression-mild, known allergies to penicillin (PCN), patient was diagnosis (dx) with Covid 19 on 20Nov2020. Concomitant medication included duloxetine, hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), colecalciferol (VITAMIN D), paracetamol (TYLENOL) and MV, all received within 2 weeks of vaccination. The patient experienced fatigue, fever, chills, body aches, headache that lasted about 24 hours, all started from 29Dec2020 11:45. Then continued fatigue and mild body aches since then. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
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| 40 | 2021-01-07 | pain in extremity, pain |
Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold s...
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Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days
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| 40 | 2021-01-07 | pain in extremity |
Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started a...
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Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours
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| 40 | 2021-01-07 | pain in extremity, weakness |
I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time wa...
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I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day! Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th
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| 40 | 2021-01-07 | tingling |
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ...
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Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
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| 40 | 2021-01-07 | feeling hot |
Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal...
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Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.
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| 40 | 2021-01-07 | pain | Severe Headaches Body aches Fatigue Chest pain allergies worsened |
| 40 | 2021-01-07 | pain |
Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, los...
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Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite
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| 40 | 2021-01-07 | lethargy, bell's palsy, dizziness, tingling, numbness |
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ...
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Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
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| 40 | 2021-01-07 | numbness |
acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral nu...
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acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: FK1730, via an unspecified route of administration at Left arm from 19Dec2020 09:15 to 19Dec2020 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. Concomitant medication included acetylcarnitine (ACETYL L CARNITIN), magnesium, colecalciferol (VITAMIN D), and probiotics. On 29Dec2020 16:30, the patient developed acute bilateral numbness in her thumb and first 3 fingers, with loss of dexterity. It lasted approximately 30-45 minutes, and then improved somewhat but it continues to be present in all digits. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. The outcome of the events was not recovered.
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| 40 | 2021-01-07 | tremor, migraine |
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ...
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bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
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| 40 | 2021-01-07 | dizziness, pain |
fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil ...
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fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil at 230 pm and tylenol at 330 pm on 01/08/2021. Pt. states that she is feeling much better after tylenol.
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| 40 | 2021-01-07 | pain |
fever 103, chills, achy body. Fever broke 2nd of January. Headache beginning on the 5th ended on th...
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fever 103, chills, achy body. Fever broke 2nd of January. Headache beginning on the 5th ended on the 7th that may or may not be related.
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| 40 | 2021-01-07 | pain in extremity |
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour...
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low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
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| 40 | 2021-01-07 | numbness |
neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-ti...
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neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-time episode of upper extremity (UE) numbness; This is a spontaneous report from a contactable health care professional (patient). A 40-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) at single dose via an unknown route at left arm on 26Dec2020 for Covid-19 immunization. COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history was reported as "none". Patient had no COVID prior vaccination, further reported as patient was not diagnosed with COVID-19 prior to vaccination. No known medications, food, or other products allergies. Concomitant drugs (Other-medications-in-two weeks) included levocabastine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) as needed, ibuprofen (MOTRIN), and multivitamin. No other-vaccine-in-four weeks received. Patient experienced adverse-event of neuropathy, which started acutely in feet bilaterally and now (as of 02Jan2021) persist intermittently in left extremities (LEs). One-time episode of upper extremity (UE) numbness. No weakness. Patient inquired if 2nd dose should be held. Adverse-event-start-date was 26Dec2020. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received. The event was reported as non-serious. Since the vaccination, patient had not been tested for COVID-19. Outcome of the event was not resolved. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral neuropathy and upper extremity (UE) numbness due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-07 | pain in extremity | sore arm, headache, chills, fatigue |
| 40 | 2021-01-08 | pain in extremity |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-08 | pain |
Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Bod...
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Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)
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| 40 | 2021-01-08 | pain in extremity | Nausea, headache and arm pain |
| 40 | 2021-01-08 | dizziness | dizziness, fever, chills, tachycardia > 90 bpm |
| 40 | 2021-01-09 | dizziness, numbness |
11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, sev...
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11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain
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| 40 | 2021-01-09 | pain |
Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fa...
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Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.
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| 40 | 2021-01-09 | pain | Fever, chills, body aches, nausea, headache |
| 40 | 2021-01-09 | pain, numbness |
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ...
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I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
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| 40 | 2021-01-09 | difficulty speaking |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-09 | tenderness |
Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen co...
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Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen compared to the left and is very painful. I am under the assumption this is likely a swollen lymph node post second vaccination. I have taken ibuprofen in attempt to help with pain and inflammation but does not seem to be helping much at this time. I anticipate this will improve over time.
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| 40 | 2021-01-10 | feeling hot |
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ...
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0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
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| 40 | 2021-01-10 | dizziness |
24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous rep...
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24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP. A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.
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| 40 | 2021-01-10 | tingling |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | pain |
C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 d...
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C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.
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| 40 | 2021-01-10 | pain in extremity |
On Friday I developed soreness in neck slowly spreading from left to right and still ongoing today w...
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On Friday I developed soreness in neck slowly spreading from left to right and still ongoing today which is Monday. Having upper back and neck pain and aching in right arm and spasms in right shoulder. Have used heat, nsaids, Tylenol, and muscle relaxers. May feel slightly improved today but not much. This could be coincidental but figured I should report in case others have experienced or will experience. I do not recall hurting my neck.
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| 40 | 2021-01-10 | weakness, dizziness, feeling hot |
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde...
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Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
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| 40 | 2021-01-10 | pain in extremity |
Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for ano...
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Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for another 24 hours. Joint pain, headache and low grade fever for 48 hours.
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| 40 | 2021-01-10 | pain |
Started out with my shoulder blades being sore that night. I woke up the next morning and was sore a...
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Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards. I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.
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| 40 | 2021-01-10 | difficulty speaking |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | dizziness |
Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasova...
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Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.
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| 40 | 2021-01-10 | pain, migraine | chills, body aches and migraine beginning on 1/4/21 and lasting until 1/6/21. |
| 40 | 2021-01-10 | dizziness |
lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine ...
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lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours
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| 40 | 2021-01-10 | numbness, tingling, weakness |
shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours af...
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shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.
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| 40 | 2021-01-11 | lethargy, pain |
Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, ...
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Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, severe body aches, chills, and lethargy
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| 40 | 2021-01-11 | pain in extremity |
Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on K...
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Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.
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| 40 | 2021-01-11 | pain in extremity |
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evo...
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Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
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| 40 | 2021-01-11 | weakness |
Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontane...
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Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.
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| 40 | 2021-01-11 | dizziness, numbness |
Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face...
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Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face and it was affecting vision a little. Called them and they told me to come back. I felt light headed and they put me in the wheelchair and took me to ER. ER: assessed by Dr: heart monitor for 30 minutes. Sent me home to watch my symptoms. Numbness in my face lasted into next day but then went away after that. Still having dizziness on and off since I've received the shot. Headaches - having them, too, off and on. TeleMed appt with DR on 7th. She recommended a MRI of brain - normal.
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| 40 | 2021-01-11 | pain |
Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, wa...
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Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.
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| 40 | 2021-01-11 | pain | Headache, fever, body pain |
| 40 | 2021-01-11 | pain in extremity |
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec...
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Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
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| 40 | 2021-01-11 | pain |
about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Feve...
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about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Fever, Headache. Stated that a few hours later she started with diarrhea
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| 40 | 2021-01-11 | pain in extremity |
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021...
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lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
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| 40 | 2021-01-11 | weakness |
severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant w...
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severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
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| 40 | 2021-01-11 | pain |
swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours...
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swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic
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| 40 | 2021-01-12 | pain, numbness, tingling |
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my va...
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?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd. when walking, standing I felt an odd sensation in my left foot/lower calf area. I had body aches mild which progressed at night especially pain running down my left side of my body. The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf. My My left foot was swollen as well as my shoe fit tighter. I also had a numbing sensation through the leg. I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot. The swelling remained and I worried I might have a DVT. I called my primary care DR office and they said I should go to the ER. I called employee health at my job and they told me go to the ER. So on 12/29/2020 I went to the ER. The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling. My US venous doppler showed negative for DVT however a significantly enlarged lymph node. As of today the swelling is much improved however still slight. The sensation in my left foot is still not the same as before. I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
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| 40 | 2021-01-12 | pain | Fever Body aches Headache Chills Shaking Nausea |
| 40 | 2021-01-12 | dizziness, numbness, tingling |
I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was init...
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I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was initially some mild tingling in extremities. After an hour later, my legs were almost numb and I had difficulty moving them. The fatigue got increasingly worse
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| 40 | 2021-01-12 | tenderness, pain, feeling hot |
I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painf...
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I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
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| 40 | 2021-01-12 | pain in extremity | Left arm pain, headache, chills. Resolved. |
| 40 | 2021-01-12 | pain, lethargy | Nausea, Vomiting, lethargy, pain, loose stools. |
| 40 | 2021-01-12 | lightheadedness, dizziness, pain |
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus...
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Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
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| 40 | 2021-01-12 | swollen extremities | Starting the day after the injection she began experiencing pain and swelling in her armpit. |
| 40 | 2021-01-12 | numbness, tingling |
Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbnes...
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Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm, on 06Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included chronic migraine and allergies to medications, food, or other products including penicillin. Concomitant medication included ethinylestradiol, levonorgestrel (SRONYX) for birth control. The patient previously took piroxicam and experienced allergy. The patient was not pregnant. The patient was not diagnosed with covid-19 prior to vaccination nor was she tested for Covid-19 since vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5 on 07Jan2021, 10:00 AM, with outcome of not recovered. The events were reported as non-serious with no treatment received.
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| 40 | 2021-01-12 | pain |
about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms ...
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about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms resolved 48 hours post injection but had upset stomach and loose stool which persisted. 1st injection just had soreness at site and a mild headache
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| 40 | 2021-01-12 | pain | covid r/u body aches, otitis media |
| 40 | 2021-01-12 | pain |
drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vacc...
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drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination
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| 40 | 2021-01-12 | pain | headache, soreness, fever, cough and sore muscles |
| 40 | 2021-01-12 | dizziness, pain |
lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. T...
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lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. These symptoms lingered into the next day causing me to stay home from work the following day.
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| 40 | 2021-01-13 | tingling |
After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in he...
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After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in her feet and traveled up her legs. Patient refused PO benadryl but took Cetirizine 10 mg PO X 1. Patient was instructed to wait for 30 minutes of observation. At that time, the patient reported that the tingling sensation remained. The patient was offered to be taken to the emergency department, but decided to leave against medical advice.
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| 40 | 2021-01-13 | pain in extremity |
Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that...
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Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.
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| 40 | 2021-01-13 | pain |
Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen...
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Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given. No problem until following day, late morning. Ibuprofen and tylenol alternating. Swelling and redness at injection site have increased daily.
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| 40 | 2021-01-13 | dizziness |
Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would po...
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Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would pop up on hands and elbows, and right foot that would itch and come and go, but the bumps on the left leg wont go away. I have taken benadryl (2 adult tablets each night), hydrocortisone cream, alcohol rub, and still hasn't gone away a week later. Headache for 7 days. A little dizziness.
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| 40 | 2021-01-13 | tingling |
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle...
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In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
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| 40 | 2021-01-13 | tingling, weakness |
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting....
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Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
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| 40 | 2021-01-13 | pain |
Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight naus...
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Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea
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| 40 | 2021-01-13 | dizziness |
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio...
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Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
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| 40 | 2021-01-13 | dizziness |
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand...
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Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
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| 40 | 2021-01-13 | pain |
onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling w...
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onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.
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| 40 | 2021-01-14 | lightheadedness, tingling, dizziness |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | dizziness |
15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. Sh...
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15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. She received Epinephrine 0.3 mg IM, solumedrol, and Benadryl. She remained hemodynamically stable.
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| 40 | 2021-01-14 | tremor |
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro...
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Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 40 | 2021-01-14 | pain | Body aches, fatigue, chills |
| 40 | 2021-01-14 | feeling cold, feeling hot, dizziness |
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing...
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I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
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| 40 | 2021-01-14 | numbness, tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minu...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minutes after injection. Resolved approximately 2-3 hours later.
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| 40 | 2021-01-14 | pain | fever, body aches, cold symptoms |
| 40 | 2021-01-14 | pain in extremity |
partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I...
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partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 40 | 2021-01-14 | pain, migraine |
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause...
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within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
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| 40 | 2021-01-15 | swollen extremities |
1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 h...
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1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 hours (8pm) I developed pain and swelling in my left armpit. I went to bed and woke up with the same swelling and pain. Checked in at Urgent Care 1/15/20 swelling started in glands in neck around mid day.
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| 40 | 2021-01-15 | numbness |
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ...
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Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
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| 40 | 2021-01-15 | pain |
Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for ...
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Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for a little bit. Woke up to eat around 6pm on 1/13/21 and started to get chills and not feeling well along with the headache and fatigue so decided to lie back down. Woke up 1:30am on 1/14/2021 soaked in sweat and nauseous still having all the other symptoms. Took oral temp and was 101.4 shortly after vomited and started having some body aches and went back to bed. Woke back up 5am on 1/14/2021 fever had broke, still had headache, fatigue, and some chills and went to work, took imitrex to help with headache. 1/15/2021 woke up at 4:30am with slight headache feeling much better and by 1/16/21 most symptoms have subsided or gotten extremely better.
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| 40 | 2021-01-16 | dizziness, weakness | Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea. |
| 40 | 2021-01-16 | pain in extremity, migraine |
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in...
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Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
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| 40 | 2021-01-17 | tingling | - My fingers are tingling - I can't grab anything or type very well |
| 40 | 2021-01-17 | pain |
Received dose 1 of vaccine and on day of and day after of vaccine administration experienced headach...
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Received dose 1 of vaccine and on day of and day after of vaccine administration experienced headache, chills, fatigue. and body aches--all flu like symptoms pregnancy info not avl from report filed.
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| 40 | 2021-01-17 | pain in extremity |
severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5...
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severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose. The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date. Information on lot/batch number has been requested.
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| 40 | 2021-01-18 | pain |
I had two am Jan 9, chills, aches, low grade temperature. That lasted about 24 hours. Malaise - ext...
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I had two am Jan 9, chills, aches, low grade temperature. That lasted about 24 hours. Malaise - extreme -lasted the same amount of time. I took Tylenol twice.
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| 40 | 2021-01-19 | numbness |
1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE S...
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1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE STILL IS EXPERIENCING IT BUT HAS SLIGHTLY IMPROVED IN SENSATION
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| 40 | 2021-01-19 | pain |
1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smel...
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1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.
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| 40 | 2021-01-19 | tingling, dizziness, numbness |
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21...
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Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
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| 40 | 2021-01-19 | pain | Fatigue, Sore Throat, Runny Nose, General Malaise, Body aches, Swollen Arm |
| 40 | 2021-01-19 | pain, dizziness |
Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, ...
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Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, clavicle and neck.
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| 40 | 2021-01-19 | dizziness, lethargy |
Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous repo...
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Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
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| 40 | 2021-01-19 | pain |
Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08J...
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Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-19 | pain, pain in extremity |
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le...
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Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-19 | pain, restlessness, pain in extremity, feeling cold, feeling hot |
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera...
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Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
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| 40 | 2021-01-19 | pain, vertigo | Ongoing treatment for vertigo |
| 40 | 2021-01-19 | pain |
Received vaccine at 1100. Patient woke up at 0151 with headache, chills and body aches. Symptoms ...
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Received vaccine at 1100. Patient woke up at 0151 with headache, chills and body aches. Symptoms the same this afternoon at 1200.
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| 40 | 2021-01-19 | pain in extremity |
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both...
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Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
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| 40 | 2021-01-19 | pain | Sudden sharp pain (whole body ) |
| 40 | 2021-01-19 | nerve pain, pain in extremity |
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit wi...
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Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
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| 40 | 2021-01-19 | tingling, numbness | Upper back pain, shoulder and neck pain, numbness in arms, tingling- ongoing for one week |
| 40 | 2021-01-20 | numbness, dizziness |
Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upp...
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Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
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| 40 | 2021-01-20 | pain in extremity, pain |
temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experien...
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temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-21 | pain |
101 fever and sever body aches 12 hours after second dose. Extreme fatigue for another 24 hours. 36...
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101 fever and sever body aches 12 hours after second dose. Extreme fatigue for another 24 hours. 36 hours after vaccine felt perfectly normal again.
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| 40 | 2021-01-21 | pain in extremity | 5PM - SORE ARM (UNABLE TO LIFT) 4AM - CHILLS 2PM - FEVER 101.2 TOOK TYLENOL |
| 40 | 2021-01-21 | dizziness |
After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart ...
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After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart rate (approximately 180). She sat back down for a few minutes and her heart rate slowly decreased. However, when she collected her belongings and began to walk , she noticed that her heart rate increased again and she felt dizzy. She stopped by a clinic within the hospital to have her heart rate checked on a pulse oximeter. It was reading about 130, but varied from 109 up to 140's/150's. She then called her doctor who encouraged her to contact the clinic. She does not feel unwell while at rest but did have dizziness when walking. After visiting with Dr she was escorted to the Emergency Department for evaluation.
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| 40 | 2021-01-21 | pain | Body ache headache stiff neck stomach pain nausea vomiting arm swelling |
| 40 | 2021-01-21 | feeling hot, weakness, dizziness |
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm...
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I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-21 | migraine |
Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- m...
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Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- muscle soreness at site, migraine that evening, and severe neck pain. Muscle pain in neck and shoulders for a few days causing ha?s in the evenings.
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| 40 | 2021-01-21 | pain |
No symptoms or reactions immediately. Injection site was very sore the following day. Followed by b...
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No symptoms or reactions immediately. Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.
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| 40 | 2021-01-21 | tingling |
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and acr...
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Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
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| 40 | 2021-01-21 | vertigo, dizziness | dizziness and vertigo |
| 40 | 2021-01-24 | pain | Headache, fever, chills, body aches, joint pain on 1/24/21. Treating with Tylenol. |
| 40 | 2021-01-24 | pain, vertigo, dizziness |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | swollen extremities | Lymph Nodes under armpit extremely swollen and painful. Unable to lift arm completely without pain |
| 40 | 2021-01-24 | dizziness, lightheadedness |
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.
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| 40 | 2021-01-24 | dizziness, lightheadedness |
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.
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| 40 | 2021-01-24 | feeling hot |
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,...
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beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
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| 40 | 2021-01-25 | pain | 15 hours post vaccination, I am experiencing headache, nausea, fever, and body aches |
| 40 | 2021-01-25 | tingling, numbness |
5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified ...
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5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified the nurse. She left to get the head nurse. Within 2 minutes my arm was numb below my elbow. This lasted 10 minutes. The feeling came back. Later that day my left upper back was sore. Since then (2 weeks) I still have numbness and tingling in my elbow and left pinky finger with occasional pain in my left upper back.
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| 40 | 2021-01-25 | pain in extremity, numbness |
Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; Thi...
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Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.
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| 40 | 2021-01-25 | numbness | Numbness of all 10 toes |
| 40 | 2021-01-25 | feeling hot |
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte...
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On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
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| 40 | 2021-01-25 | pain |
Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneou...
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Rashes to upper body anterior and posterior; Generalized body pain; chest pain; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 40 | 2021-01-25 | pain |
Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from...
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Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from a contactable physician (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL), ibuprofen and biotin, cyanocobalamin, folic acid (MVI 3). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020 07:15 on the right arm for COVID-19 immunization. On 11Jan2021 21:30 (reported as 'after 12 hours'), the patient experienced severe body aches, chills, headache and temp 100, then after 48 hours (Jan2021) those symptoms resolved, but had GI upset and diarrhea. The patient underwent lab tests and procedures which included body temperature: 100 (no unit reported) on 11Jan2021. The outcome the events severe body aches, chills, headache and temp 100 was recovered on Jan2021 (reported as after 48 hours those symptoms resolved) while GI upset and diarrhea was recovering. The patient did not received any treatment for the reported events.
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| 40 | 2021-01-25 | feeling hot, tingling, dizziness |
a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super di...
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a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super dizzy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 12Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history. The patient is not pregnant. Concomitant medication included amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced super dizzy on 12Jan2021 10:06, a flood of heat throughout her body, pain in her calf muscle, tingling, and it woke her up all night on 12Jan2021 12:00. Outcome of the events was recovering.
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| 40 | 2021-01-25 | dizziness |
difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other health...
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difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on the left arm on 06Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto, seasonal allergies, ripe food, allergies to weed, grass, trees. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), fexofenadine hydrochloride (ALLEGRA) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took erythromycin, Bactrim and experienced allergies. Patient did not have COVID and did not receive other vaccines four weeks prior to vaccination and was not pregnant. The vaccine was received at a workplace clinic. On 06Jan2021 10:45, the patient experienced difficulty falling asleep and was lightheaded. No treatment was received for the events. The patient has not tested for COVID post vaccination. Outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-25 | migraine |
nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigo...
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nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
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| 40 | 2021-01-25 | pain | pain, redness, and warm to touch, progressively has gotten worse |
| 40 | 2021-01-26 | feeling hot |
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap...
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About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
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| 40 | 2021-01-26 | dizziness |
After my 1st vaccine I felt dizzy and experienced headaches. I tested positive for Covid 19 on 12-30...
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After my 1st vaccine I felt dizzy and experienced headaches. I tested positive for Covid 19 on 12-30-2020.
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| 40 | 2021-01-26 | dizziness |
After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP...
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After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.
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| 40 | 2021-01-26 | pain |
After second dose about 16 hours after experienced chills bodyaches sore joints muscles and low grad...
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After second dose about 16 hours after experienced chills bodyaches sore joints muscles and low grade fever and fatigue
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| 40 | 2021-01-26 | weakness, slurring, dizziness |
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync...
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Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
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| 40 | 2021-01-26 | pain in extremity |
I had soreness in my arm the day after the first injectionbut no other adverse events after the firs...
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I had soreness in my arm the day after the first injectionbut no other adverse events after the first injection; This is a spontaneous report from a contactable Other-HCP (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EH9899), via an unspecified route of administration on 18Dec2020 14:45 at single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years). There were no concomitant medications. No other vaccine received in four weeks. Facility type vaccine was hospital. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had soreness in her arm the day after the first injection but no other adverse events after the first injection. No treatment received. Outcome of the event was recovered.
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| 40 | 2021-01-26 | numbness |
Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She ...
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Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She then stared to drive herself home and developed numbness to the right lateral face and right neck. She came back the vaccine site and had numbness to her left lateral face. She was was without edema, impaired vision, talking, swallowing and her neuro exam was normal.
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| 40 | 2021-01-26 | dizziness |
Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a co...
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Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.
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| 40 | 2021-01-26 | pain in extremity, feeling cold |
RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AR...
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RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
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| 40 | 2021-01-26 | pain |
body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels li...
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body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.
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| 40 | 2021-01-26 | weakness |
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr...
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heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
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| 40 | 2021-01-28 | numbness, tingling |
Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a cont...
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Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on the right arm on 08Jan2021 at 07:15 at a single dose for COVID-19 immunization. Medical history included anemia, Vitamin D deficiency, and known allergies to dairy and kiwi. Concomitant medication included iron (IRON), colecalciferol (VITAMIN D [COLECALCIFEROL]), zinc (ZINC), linum usitatissimum oil (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), and cetirizine (CETIRIZINE). The patient had no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, on the right arm on 19Dec2020 at 0745AM for COVID-19 immunization. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The patient experienced facial numbness and tingling on 08Jan2021 at 08:15. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.
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| 40 | 2021-01-28 | dizziness | Fatigue, fever, myalgia, headache and dizziness. |
| 40 | 2021-01-28 | pain |
I woke up at about 1am, feeling achy and with the chills. I had a fever of 102. I took Tylenol and ...
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I woke up at about 1am, feeling achy and with the chills. I had a fever of 102. I took Tylenol and went back to bed. I woke up about 8 feeling exhausted and achy. I took more Tylenol and started to feel better for a few hours. About 12pm I started to feel worse again and took a nap until about 3pm. When I got up at 3pm I had the chills and could barely get out of bed. I had a fever that alternated between 104 - 105 until 6pm. The fever broke around 6pm and I was still a bit achy and exhausted, but started progressively feeling better. I felt totally fine the next morning.
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| 40 | 2021-02-01 | pain in extremity |
Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left ...
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Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache. Lasted approximately 12 hours
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| 40 | 2021-02-01 | pain | Vomiting, diarrhea, fever, generalized intense pain. Fatigue still experiencing at this time |
| 40 | 2021-02-02 | difficulty speaking, numbness, tingling |
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o...
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tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-03 | numbness, tingling, pain in extremity, pain |
12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1...
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12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1-2 days later without inciting event (no trauma, no sports/weights), progressively worsening to severe next 2 days with onset of numbness and paresthesias in left upper arm and hand by 1/5/2021 seen at urgent care with dx: Cervical Neuropathy. Follow-up cervical MRI 1/22/21 without significant canal or foraminal impingement. Seen by Neurologist 2/3/2021, at that time pain improved and localized to left shoulder joint area radiating under scapula and paresthesia resolved to numbness. Physical exam findings: Absent triceps reflex, Left FDI atrophy, left hand finger extensor weakness, left abduction limited to 90 degrees. Dx: Neurologic Amyotrophy (Parsonage Turner Syndrome); Complication of COVID vaccination. Plan: EMG, NCS, Left shoulder MRI, labs pending. PT OT ordered. Rx: Nortriptyline, Medrol Dosepak. F/U 2-3 months with neurology.
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| 40 | 2021-02-04 | pain |
Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is...
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Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 15Jan2021 07:00 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient has no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient mentioned that the next day after the shot (16Jan2021 at 05:30), the patient feel a pain under her left arm; days later, the pain increased, and she thinks it is lymphoma. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.
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| 40 | 2021-02-04 | tenderness |
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey...
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Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-07 | pain | 8 DAYS ONGOING, NAUSEA, BODY ACHES, NECK MUSCLE TIGHTNESS, LOW GRADE FEVER, DIAPHRESIS, HEADACHES |
| 40 | 2021-02-07 | pain |
CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN...
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CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN, GREY COMPLEXION, MALAISE, GENERALIZED JOINT PAIN. DIFFICULTY RAISING UPPER EXTREMITIES DUE TO PAIN AN MUSCLE WEAKNESS,
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| 40 | 2021-02-07 | tremor, tingling, dizziness, weakness |
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were ...
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inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 40 | 2021-02-08 | dizziness, tingling, numbness |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-10 | pain |
Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after ...
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Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
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| 40 | 2021-02-10 | feeling hot |
Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is ...
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Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 40 | 2021-02-16 | facial paralysis, numbness |
mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her ...
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mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.
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| 40 | 2021-02-18 | nerve pain |
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar...
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Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
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| 40 | 2021-02-21 | dizziness, tingling, numbness, weakness |
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti...
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A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. Â This lasted about an hour (15 hrs post-vaccine).
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| 40 | 2021-02-21 | facial paralysis |
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da...
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After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
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| 40 | 2021-02-21 | dizziness |
Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, ...
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Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.
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| 40 | 2021-02-21 | dizziness, tingling |
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ...
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malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
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| 40 | 2021-02-22 | dizziness, tremor |
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat...
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Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
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| 40 | 2021-02-22 | pain |
Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I ha...
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Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.
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| 40 | 2021-02-22 | dizziness, speech disorder |
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph...
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Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
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| 40 | 2021-02-22 | lethargy | Systemic: Exhaustion / Lethargy-Medium |
| 40 | 2021-02-22 | pain in extremity |
Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted fo...
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Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted for the three weeks until I got my second dose in my left arm. The left arm just had a normal aching for 24 hours. My right arm has rapid twitches like once or twice a day.
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| 40 | 2021-02-22 | facial paralysis |
swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have litt...
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swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, "I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement." The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 40 | 2021-02-24 | dizziness |
light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other H...
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light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization. Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 40 | 2021-02-25 | tingling, numbness |
Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right e...
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Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right eye twitching daily; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the second dose of BNT162B2 (lot number: EG686), intramuscularly in left arm on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took tramadol and experienced drug allergy, and the first dose of BNT162B2 (lot number: GK5730) in left arm for COVID-19 immunisation. The patient experienced parethesias, on lower extremities and tingling on right arm all day, intermittent numbness, right eye twitching daily on 15Jan2021. The patient underwent lab tests and procedures which included nasal swab, COVID test result: Negative on an unspecified date. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for these events. Patient was not recovered.
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| 40 | 2021-02-28 | pain in extremity |
After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting head...
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After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information about batch/lot number has been requested.
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| 40 | 2021-02-28 | pain in extremity |
arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contact...
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arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-02-28 | dizziness, feeling hot |
felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood press...
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felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
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| 40 | 2021-02-28 | dizziness, pain in extremity |
felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Fri...
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felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-03-02 | dizziness, tingling |
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef...
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Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
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| 40 | 2021-03-02 | migraine, dizziness |
chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue seve...
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chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.
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| 40 | 2021-03-03 | pain |
Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report f...
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Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 16Feb2021 10:00 AM (age at vaccination was 40 years old, vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 26Jan2021 11:15 AM (vaccine location: Right arm) at single dose for COVID-19 immunisation. The patient's medical history included environmental allergies. The concomitant medications were reported none.Patient experienced chills, body aches lasting a while, joint pain everywhere and headache, all starting 14 hours and 30 mins after second dose on 17Feb2021.The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.
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| 40 | 2021-03-07 | tingling |
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre...
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Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
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| 41 | 2020-12-31 | migraine | Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days |
| 41 | 2020-12-31 | dizziness, tremor, pain |
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe...
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Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
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| 41 | 2021-01-01 | pain, balance disorder, weakness |
Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and b...
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Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.
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| 41 | 2021-01-02 | dizziness |
A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observ...
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A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observed for a few minutes and she stated that the dizziness was worse and that she felt flushed so she was given 0.3mg of IM epinephrine after which she began to immediately improve. She was also given 50mg PO diphenhydramine. She was observed for 60 minutes after the epinephrine dosing without any recurrence of her symptoms and she was discharged home with strict ER return precautions.
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| 41 | 2021-01-02 | pain in extremity | Sore arm, diarrhea, low grade fever. No treatment. |
| 41 | 2021-01-03 | pain in extremity |
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo...
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12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
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| 41 | 2021-01-03 | numbness, dizziness, weakness, unresponsive to stimuli |
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ...
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12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
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| 41 | 2021-01-03 | pain |
The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on ...
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The next day on 12/19 I was super sore. On 12/20 really bad joint pain and I had rash located on my face and chest. I went to PCP on 12/21 seen PCP given EpiPen.
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| 41 | 2021-01-04 | tremor |
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patien...
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15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
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| 41 | 2021-01-04 | pain | 4 days the vaccine I got a high fever, body aches and tonsils were severly swollen and couldnt work |
| 41 | 2021-01-04 | pain, weakness |
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t...
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I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
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| 41 | 2021-01-04 | pain, tingling |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-04 | pain |
On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and...
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On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
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| 41 | 2021-01-04 | pain in extremity | PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site |
| 41 | 2021-01-04 | pain |
after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to m...
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after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to miss work
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| 41 | 2021-01-04 | vertigo |
episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one ...
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episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one is the patient). A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 at 12:45 at a single dose for immunization. Medical history included benign paroxysmal positional vertigo, but the patient has not had a flare of this condition in 3.5 years. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient who has a history of Benign Paroxysmal Positional Vertigo (BPPV) had not had a flare of this condition in 3.5 years. Previously, it has only been brought on by scuba diving, then she woke up the day after receiving the Pfizer COVID 19 vaccine, on 23Dec2020 at 06:30 with an episode of vertigo consistent with prior episodes of BPPV. She has associated nausea and vomiting, and her symptoms mostly resolve with doing home exercises, rest and time. On 29Dec2020, that is day 7 after the vaccine and she still have mild vertigo. She has no fevers, chills, or myalgias. She stated that perhaps it was a coincidence but thought it might be worth reporting, and she fully intend to get the second Pfizer vaccine when available. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications were received by the patient within 2 weeks of vaccination. The events nausea and vomiting resolved in 2020 while the rest of the events was resolving.
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| 41 | 2021-01-05 | tingling |
Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minute...
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Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minutes, tingling & facial muscle tightness around mouth. Twitching & facial mouth muscle tightness for about 4 days, diminishing each day. Vaccine was given Wed evening...finally Sun was little to none symptoms.
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| 41 | 2021-01-05 | numbness, pain in extremity | LEFT ARM PAIN AND NUMBESS IMEDIATELY POST VACCINATION. |
| 41 | 2021-01-05 | feeling hot | TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT |
| 41 | 2021-01-05 | dizziness |
approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1...
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approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1 hour after vaccine she had a headache. I took her blood pressure, it was 158/83, Pulse 92, Respirations 20, not shortness of breath or respiratory difficulty noted. She laid down and continued to feel the same way after 2 hours post vaccination. Her husband picked her up and she went home to rest for the day. She was given instructions on when to seek medical attention and to call me later today to let me know how she is feeling.
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| 41 | 2021-01-06 | dizziness |
24 hours post-vax woke with severe dizziness severe, fatigue, and muscle aches. Fever from 12/21 -12...
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24 hours post-vax woke with severe dizziness severe, fatigue, and muscle aches. Fever from 12/21 -12/22 21, peak temp 102.9. However, I am breastfeeding and suspect I may have had mastitus. Took measures to hydrate and express milk to ensure that was treated. Spoke to NP in the ER unit, did not take prescribed meds since fever broke.
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| 41 | 2021-01-06 | pain in extremity, migraine |
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site...
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24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
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| 41 | 2021-01-06 | dizziness |
Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narra...
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Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
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| 41 | 2021-01-06 | pain |
Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vo...
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Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain
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| 41 | 2021-01-06 | pain in extremity, pain |
I Initially just had a sore left arm which felt better the next day. I woke up the morning after t...
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I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
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| 41 | 2021-01-06 | dizziness | Light headedness, skin flushing, syncope |
| 41 | 2021-01-06 | pain in extremity |
Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore ...
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Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore right arm lasting about 72 hours.
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| 41 | 2021-01-06 | pain in extremity |
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt...
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Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
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| 41 | 2021-01-06 | pain |
Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was int...
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Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was intoxicated. this passed after a few hours. Narrative: Employee missed greater than >1 days of work second to symptoms (aches and extreme fatigue)
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| 41 | 2021-01-06 | pain in extremity, pain |
Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness...
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Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness and body aches with improvement.
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| 41 | 2021-01-06 | pain | after receiving vaccine patient has hives on arm & body aches |
| 41 | 2021-01-06 | migraine |
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and...
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site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
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| 41 | 2021-01-06 | feeling hot, tingling |
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ...
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tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
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| 41 | 2021-01-06 | pain |
woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F...
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woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
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| 41 | 2021-01-07 | pain, pain in extremity |
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache...
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Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-07 | pain | Achy body, headache, ear ringing, chills and a temperature. |
| 41 | 2021-01-07 | pain in extremity |
Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection ar...
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Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
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| 41 | 2021-01-07 | dizziness | Dizziness, unable to walk but she is okay now |
| 41 | 2021-01-07 | weakness, pain, pain in extremity |
Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, b...
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Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.
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| 41 | 2021-01-07 | feeling hot |
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur...
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Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
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| 41 | 2021-01-07 | tenderness, pain |
Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, li...
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Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days. I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling. It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)
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| 41 | 2021-01-07 | lethargy |
Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy ...
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Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.
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| 41 | 2021-01-07 | vertigo, dizziness |
Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained o...
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Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.
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| 41 | 2021-01-07 | dizziness |
Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and ...
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Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.
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| 41 | 2021-01-07 | pain |
Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, local...
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Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, localized discomfort
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| 41 | 2021-01-07 | pain in extremity |
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and la...
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Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
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| 41 | 2021-01-07 | pain in extremity, weakness |
Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatig...
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Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue
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| 41 | 2021-01-07 | pain |
Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? kno...
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Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-07 | pain, pain in extremity | body aches, fever, nausea, sore arm, up all night |
| 41 | 2021-01-07 | pain, pain in extremity | chest tightness arm pain nausea diarrhea body aches fatigue lost work two days |
| 41 | 2021-01-07 | dizziness |
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest...
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chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.
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| 41 | 2021-01-07 | dizziness | headache, sore throat, light headed, nauseous, fatigue, cold and sweaty-no fever |
| 41 | 2021-01-07 | numbness, tingling |
on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on da...
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on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 41 | 2021-01-08 | pain |
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expecte...
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2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.
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| 41 | 2021-01-08 | dizziness |
About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lig...
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About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.
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| 41 | 2021-01-08 | pain in extremity |
Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-...
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Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)
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| 41 | 2021-01-08 | dizziness |
Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue...
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Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.
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| 41 | 2021-01-08 | lightheadedness, weakness | Fever, chills, weakness, myalgias, near syncope, increased heart rate. |
| 41 | 2021-01-08 | nerve pain | Nerve pain L face/head 9/10 pain gradual improvement over 7 days |
| 41 | 2021-01-08 | pain |
Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and pro...
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Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches
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| 41 | 2021-01-08 | pain |
Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. To...
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Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.
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| 41 | 2021-01-08 | tenderness |
Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after re...
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Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular
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| 41 | 2021-01-08 | tingling |
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci...
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Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
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| 41 | 2021-01-08 | dizziness, lethargy |
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of h...
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employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
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| 41 | 2021-01-09 | pain | 1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches |
| 41 | 2021-01-09 | numbness |
About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 m...
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About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.
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| 41 | 2021-01-09 | pain | Chills, headache, body aches, fatigue |
| 41 | 2021-01-09 | pain | Fever(low grade) , body aches, headaches, dirrhea, chills |
| 41 | 2021-01-09 | dizziness, numbness, pain |
HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55P...
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HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD
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| 41 | 2021-01-09 | feeling hot, dizziness |
I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I ...
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I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.
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| 41 | 2021-01-09 | pain |
I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12...
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I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12/29/2020. I started feeling unwell on 12/31/20. On 1/1/2021, chills and body aches started for two days. I continue to have daily headaches and off and on chills and body aches. Other symptoms are congestion, running nose and diarrhea.
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| 41 | 2021-01-09 | pain |
Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme...
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Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme fatigue and headaches 2 days, normal fatigue and nausea about a week.
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| 41 | 2021-01-09 | pain | Severe muscle aches (all throughout body), chills, feverish, fatigue |
| 41 | 2021-01-09 | feeling hot, tremor, dizziness |
Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was g...
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Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was going to pass out. I gave the patient one 25mg Benadryl at 11:18 and orange juice. Within a few minutes of taking the Benadryl and also being able to take in air outside the mask her symptoms improved and felt herself.
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| 41 | 2021-01-10 | pain in extremity | Arm Soreness, redness around injection site |
| 41 | 2021-01-10 | dizziness | Develops dizziness on 1/7/2021, intermittent that lasted till 1/8/2021. |
| 41 | 2021-01-10 | pain | HA, fatigue, low grade fever, body aches treatment include Tylenol with improvement. |
| 41 | 2021-01-10 | pain in extremity |
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a...
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I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
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| 41 | 2021-01-10 | pain |
I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer cov...
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I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer covid19 vaccine. Chills lasted for about 15min, they were of moderate intensity. Then I had low grade fever, body ache and tiredness for the entire next day (01/08/2021); it was bad enough to interfere with my regular activities of work and childcare. I ended up taking the day off. On the following day (01/09/2021), I woke up fully restored.
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| 41 | 2021-01-10 | pain in extremity |
Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following mor...
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Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.
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| 41 | 2021-01-10 | pain in extremity, weakness, pain |
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and bo...
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Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
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| 41 | 2021-01-10 | dizziness, pain |
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-...
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Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
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| 41 | 2021-01-10 | tingling, dizziness |
Staff of facility experiences light headiness and extreme dizziness. Patient explained that her leg...
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Staff of facility experiences light headiness and extreme dizziness. Patient explained that her legs felt heavy and were very tingly. Monitored BP and remained within normal rages. Gave Benadryl at 11:35am. Patient also drank water and ate some food. After sitting for 45 minutes patient felt better
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| 41 | 2021-01-10 | dizziness | c/o palpitations, dizziness |
| 41 | 2021-01-10 | pain | fever chills HA body aches |
| 41 | 2021-01-11 | pain in extremity |
12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of...
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12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of a base ball and ER and your lynodes had swollen. Gave you IVProphen and Tylneol Took a week in a half for swollen to go down.
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| 41 | 2021-01-11 | pain |
41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes a...
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41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.
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| 41 | 2021-01-11 | pain | Body aches, fever 103, headaches, abdominal pain for 28 hours |
| 41 | 2021-01-11 | pain | Developed fever, chills, aches and fatigue within 24hour of vaccine administration |
| 41 | 2021-01-11 | dizziness, tremor |
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue...
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Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
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| 41 | 2021-01-11 | pain |
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla...
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Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
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| 41 | 2021-01-11 | dizziness, tingling | FLUSHING, LIGHT HEADED, AND TINGLING |
| 41 | 2021-01-11 | pain in extremity, tingling, feeling hot |
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h...
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Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
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| 41 | 2021-01-11 | numbness, tingling |
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ...
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I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-11 | dizziness |
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes...
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Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
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| 41 | 2021-01-11 | pain |
My scale aches and joint pain; My scale aches and joint pain; This is a spontaneous report from a co...
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My scale aches and joint pain; My scale aches and joint pain; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on 05Jan202115:00 at single dose in the left arm for COVID-19 immunization. There were no concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient reported that her scale aches and experienced joint pain, both on 05Jan2021 18:00. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: pending result on 06Jan2021. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. The outcome of the events was not recovered. The following information on the batch number has been requested.
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| 41 | 2021-01-11 | dizziness |
Patient reported to observation area for monitoring post-Injection. Â No prior history of adverse ...
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Patient reported to observation area for monitoring post-Injection.  No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.  She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.  Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling  Patient placed in supine position on stretcher, received water hard candy.  Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.  After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
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| 41 | 2021-01-11 | numbness, speech disorder |
The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of...
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The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of the mouth; difficulty speaking; her eye socket, it didn't feel like her eye was there; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK923, expiration date: Apr2021), via unknown route of administration on 30Dec2020 at single dose (first dose by injection once to left upper arm, by the shoulder, a little down) for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications were reported none. Her blood pressure was diagnosed years prior to the report, like 10+ years prior to the report, but she did not know if it had anything to do with it. The left side of her face, it didn't go completely numb on 30Dec2020, but mostly: stated her eye socket, it didn't feel like her eye was there, and her mouth, she had difficulty speaking, she still could not chew on the side of the mouth in Dec2020. Stated it felt like pulling, like something pulling, like a rope was tied and pulling backwards to the back of head and downward. States this lasted 2 days thankfully, and she did not regret getting it. She Provided weight as a lot of pounds, said she was joking. The vaccine was not prescribed by a doctor, her job offered it, she worked at a hospital, so it was voluntary and she took it. The event started maybe 6 hours after getting the vaccine, it was while she was sleeping, she woke up, she had slept, it was in the middle of the night, and was gone by Saturday for sure. This was her first dose. States site of administration was where she typically gets flu shots. The outcome of the event The left side of her face, it didn't go completely numb was recovered on 02Jan2021. The outcome of other events was unknown.
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| 41 | 2021-01-11 | one side paralysis, tingling, pain in extremity, weakness, numbness |
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial nu...
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Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
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| 41 | 2021-01-11 | tenderness | worsening of the rash developed tender/swollen supraclavicular lymph nodes |
| 41 | 2021-01-12 | feeling cold | 103 Fever 24 hrs chills 48 hrs tired 48 hrs nausea 72 hrs sweating 72 hrs headache 72 hrs |
| 41 | 2021-01-12 | feeling cold | 2 dose, feeling of being cold, not able to warm up, unable to sleep |
| 41 | 2021-01-12 | pain |
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ...
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24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
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| 41 | 2021-01-12 | pain in extremity, pain, weakness | Arm Sore, fatigue, weak, body aches, not feeling well |
| 41 | 2021-01-12 | pain in extremity |
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin...
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Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
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| 41 | 2021-01-12 | pain, inability to speak, slurring |
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre...
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Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
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| 41 | 2021-01-12 | numbness, pain |
So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 ...
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So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.
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| 41 | 2021-01-12 | pain |
Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had bo...
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Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had body ache. It progressed from there then I tested positive for Covid. I went to a clinic to get tested was given Zpac, Zythrimac, steroids' .
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| 41 | 2021-01-12 | feeling hot |
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ...
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The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
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| 41 | 2021-01-12 | migraine, pain | fever loss of appetite headache/migraine body aches muscle cramps, rash |
| 41 | 2021-01-12 | pain in extremity |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
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| 41 | 2021-01-13 | weakness, pain |
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days....
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10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
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| 41 | 2021-01-13 | feeling hot |
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm...
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1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
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| 41 | 2021-01-13 | one side paralysis, pain in extremity, pain, facial paralysis |
Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache...
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Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache, dull neck pain that extended all the way down to my left foot and left arm soreness. She noticed facial droop on the left side at which case, she decided to sleep it off. When she woke up the following morning, She still had a slight droop but not as noticeable. Symptoms disappeared approximately 24 -30 hours post injection.
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| 41 | 2021-01-13 | numbness, tingling, dizziness |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | dizziness |
Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensatio...
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Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.
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| 41 | 2021-01-13 | dizziness |
Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has ...
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Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has remained for over 24hours.
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| 41 | 2021-01-13 | tingling, dizziness |
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips...
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Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
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| 41 | 2021-01-13 | dizziness, lightheadedness, feeling hot |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | pain |
My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches...
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My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches. Consulted with my PCP who suggested a mammogram and an ultrasound. Both done at Hospital. It shows lymph nodes are swollen and a follow up appointment has been schedule for 3 months. If they are still swollen a biopsy will be made.
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| 41 | 2021-01-13 | weakness |
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a...
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Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
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| 41 | 2021-01-13 | pain | Persistent Nausea Cough, post nasal drip Mild Headache, Neck and body ache, fatigue |
| 41 | 2021-01-13 | tingling, feeling hot |
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324...
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Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
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| 41 | 2021-01-13 | tingling, pain |
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I...
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Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
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| 41 | 2021-01-13 | pain |
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu...
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Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
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| 41 | 2021-01-13 | numbness |
Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facia...
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Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs. Lymphadenopathy still severe at present.
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| 41 | 2021-01-13 | tingling, feeling hot |
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn...
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Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
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| 41 | 2021-01-13 | tingling, feeling hot, weakness |
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for...
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within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
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| 41 | 2021-01-14 | migraine |
13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (pat...
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13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: El3246, via an unspecified route of administration on Left arm from 07Jan2021 10:00 to 07Jan2021 10:00 as SINGLE DOSE (first dose) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication includes prenatal vitamins. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient experienced 13-hour migraine the day after the vaccine on 08Jan2021. The outcome of the event was recovered.
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| 41 | 2021-01-14 | pain in extremity, tremor, pain |
Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out ...
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Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain
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| 41 | 2021-01-14 | swollen extremities |
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over,...
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Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
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| 41 | 2021-01-14 | dizziness, tingling, feeling hot |
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic...
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Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
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| 41 | 2021-01-14 | tremor |
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext...
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Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
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| 41 | 2021-01-14 | pain |
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join...
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Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
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| 41 | 2021-01-14 | pain |
I had common side effects of cough/sneezing for 24-48 hours. I was 20 days post-op double mastectomy...
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I had common side effects of cough/sneezing for 24-48 hours. I was 20 days post-op double mastectomy with DIEP reconstruction. Although we knew I?d have side effects that would out weigh me getting the virus, we didn?t think ahead of that. My adverse event is that I ended up with a hernia in my lower left stomach. I have a bulge and some pain. My surgeon will be able to fix it after 3 months post-op.
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| 41 | 2021-01-14 | dizziness |
Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professio...
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Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 41 | 2021-01-14 | tingling, numbness, vertigo |
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was...
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On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.
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| 41 | 2021-01-14 | pain |
Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. A...
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Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased. Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain
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| 41 | 2021-01-14 | pain | Severe chills, fever tmax 101.2, body aches |
| 41 | 2021-01-14 | pain |
Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower bac...
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Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower back pain, fever 103, could not sleep. Took Tylenol. Today at 12 noon staff feels chill, fever 102. Now ok. W
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| 41 | 2021-01-14 | pain, pain in extremity |
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app...
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Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-14 | pain |
Within 12 hours of receiving second dose of Pfizer COVID-19 vaccine, patient developed fever 39.5, c...
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Within 12 hours of receiving second dose of Pfizer COVID-19 vaccine, patient developed fever 39.5, chills, body aches and headache. Tylenol and ibuprofen did not help with fever much. No notes on further escalation of care or resolution.
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| 41 | 2021-01-14 | dizziness |
became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED...
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became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home
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| 41 | 2021-01-14 | numbness, pain, dizziness, lethargy | lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate |
| 41 | 2021-01-15 | nerve pain |
I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side ...
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I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side of my face when my son had tested positive. Both times I got the vaccination the nerve pain in my face came back. It was fairly painful the second time. The concern is that I had an inflammatory response similar to when I actually may have had Covid both times. It went away within 48 hours and I have been done since.
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| 41 | 2021-01-15 | numbness |
Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprof...
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Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprofen and 25 mg of benedryl then went to bed (after working night shift). Upon waking around 4pm the numbness was gone
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| 41 | 2021-01-15 | pain | febrile 102.5, achy, chills, sweaty, headache |
| 41 | 2021-01-16 | feeling cold, pain |
AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine...
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AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection
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| 41 | 2021-01-16 | difficulty speaking, tingling, numbness |
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n...
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Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
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| 41 | 2021-01-16 | tremor | severe shaking chills with onset at 10pm that lasted for 2 hours, no treatments used |
| 41 | 2021-01-17 | difficulty speaking |
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t...
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Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-17 | pain in extremity | headache, dry mouth, and arm pain |
| 41 | 2021-01-17 | pain, tremor, dizziness |
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa...
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tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 41 | 2021-01-18 | pain in extremity, movement disorder |
muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong tha...
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muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about Lot/Batch has been requested.
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| 41 | 2021-01-19 | feeling hot |
5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observati...
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5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
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| 41 | 2021-01-19 | pain | Body aches, fatigue, sore throat, malaise, chills |
| 41 | 2021-01-19 | pain |
Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional n...
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Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional nausea throughout the day and fatigue.
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| 41 | 2021-01-19 | pain |
Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the s...
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Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.
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| 41 | 2021-01-19 | pain | Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness |
| 41 | 2021-01-19 | tingling |
NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED...
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NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED AFTER 15 MINUTES
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| 41 | 2021-01-19 | pain in extremity |
On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolve...
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On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.
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| 41 | 2021-01-19 | feeling hot, weakness, dizziness, numbness, tingling |
The patient self-reported this adverse reaction through the hospital electronic reporting system. I...
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The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
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| 41 | 2021-01-20 | migraine, pain |
general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spo...
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general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.
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| 41 | 2021-01-20 | pain, weakness, pain in extremity, restlessness |
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne...
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hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | facial paralysis, tingling |
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ...
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tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-01-21 | pain in extremity |
Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer ...
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Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
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| 41 | 2021-01-21 | pain |
Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injectio...
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Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)
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| 41 | 2021-01-21 | pain | I had eye pain and drainage, body aches, abdominal pain, headache and joint pain. |
| 41 | 2021-01-21 | numbness | Numbness in Left hand |
| 41 | 2021-01-21 | dizziness, tingling, feeling hot |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-21 | pain |
Same symptoms as when I actually had covid mid December. Headache, back ache, fever, chills, body ac...
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Same symptoms as when I actually had covid mid December. Headache, back ache, fever, chills, body aches
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| 41 | 2021-01-24 | tingling |
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki...
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At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
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| 41 | 2021-01-24 | dizziness |
Employee became dizzy after vaccine administration. Employee was laid down with an ice pack at the b...
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Employee became dizzy after vaccine administration. Employee was laid down with an ice pack at the back of her neck and monitored. Her heart rate was 75 and her POX was 99%. She immediately felt better.
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| 41 | 2021-01-24 | migraine, dizziness, weakness |
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right,...
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Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.
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| 41 | 2021-01-24 | pain |
I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the inject...
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I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion and overall unwell feeling. This feeling persisted through the remainder of the day. By 46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch. I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache. At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2" and swelling without redness now extends about 2" past the redness down my arm.
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| 41 | 2021-01-24 | weakness, numbness, pain in extremity |
Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibup...
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Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibuprofen; tylenol; ice to neck, shoulder and wrist; range of motion exercises; heat for muscle relaxation; rest. Decreased pain and ache with rest.
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| 41 | 2021-01-24 | pain in extremity, tingling, numbness |
On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, ...
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On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, had lumbar puncture, symptoms assessed, blood work and diagnosed with Guillian Barre.
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| 41 | 2021-01-24 | tremor, migraine, weakness, dizziness |
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose...
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following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
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| 41 | 2021-01-25 | dizziness |
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ...
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Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
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| 41 | 2021-01-25 | pain | Chills, body aches, vomiting |
| 41 | 2021-01-25 | weakness, dizziness |
Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had di...
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Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.
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| 41 | 2021-01-25 | pain | Fatigue, muscle aches/body aches and fever |
| 41 | 2021-01-25 | pain | Severe headache, muscle and body aches |
| 41 | 2021-01-25 | pain |
aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spon...
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aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), intramuscular on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), fexofenadine hydrochloride (ALLEGRA). The patient had first dose of COVID-19 vaccine on 21Dec2020 intramuscular at right arm. On 12Jan2021, the patient experienced aches, muscle pain, low grade fever, and enlarged lymphnodes left supraclavicular region. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 41 | 2021-01-26 | pain in extremity, numbness, tingling |
"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. ...
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"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. The next 48 hours the symptoms got worse, and I had paresthesia in b/l upper and lower extremities, my trunk, and my face. My symptoms resolved for 2 weeks, but returned on Jan 10th. They started the same way with numbness and paresthesia in my R great toe and have progressed since them. I'm currently have frequent episodes of paresthesia all over my body and have developed numbness and pain in my hands. I saw my primary physician on Jan 15th regarding the symptoms."
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| 41 | 2021-01-26 | involuntary muscle movements, tremor |
After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my w...
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After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my whole body. I had the chills and a headache as well as muscle aches and a sore throat. After the second dose I had the chills again, headache, fever, sore throat, severe fatigue, muscle aches, runny nose that lasted over 24 hours.
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| 41 | 2021-01-26 | weakness, pain |
Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous rep...
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Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-26 | dizziness | I had motion sickness , dizzy, and nausea. |
| 41 | 2021-01-26 | vertigo |
seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss o...
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seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-26 | numbness |
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left...
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severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
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| 41 | 2021-01-26 | weakness, pain in extremity, pain, dizziness |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-27 | pain, pain in extremity, tingling |
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. St...
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5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.
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| 41 | 2021-01-27 | numbness |
Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse...
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Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular via the left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ciprofloxacin. It was reported that the patient experienced decreased sensation in the L side of the face that lasted 3 days initially and now comes and goes on 30Dec2020 21:00. No treatment was given for the event. The outcome of the event was not recovered.
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| 41 | 2021-01-28 | dizziness |
1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states sh...
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1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist. RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left
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| 41 | 2021-01-28 | feeling hot, dizziness |
Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. asses...
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Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. assessed by staff. BP: 100/68, HR: 68, RR: 16, O2 sats: 97%. No other symptoms noted. Pt. declines to go to emergency room. Will follow up with PCP if needed.
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| 41 | 2021-01-28 | pain |
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches a...
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It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
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| 41 | 2021-01-31 | tingling |
10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S wer...
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10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S were taken, HR 80, T97.9, SpO2 98%. BP monitored BP 137/93. Pt observed for additional 15 minutes. Electrolytes given for rehydration. Discharged at 1712. Pt reported feeling better.
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| 41 | 2021-02-01 | dizziness | 4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack |
| 41 | 2021-02-03 | weakness, pain in extremity, tingling, numbness, pain |
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo...
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currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-04 | dizziness, pain |
Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lighth...
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Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid based on the known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-05 | nerve pain, pain, lethargy, pain in extremity |
After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, b...
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After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.
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| 41 | 2021-02-09 | nerve pain, tingling, pain |
Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbnes...
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Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
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| 41 | 2021-02-21 | dizziness, unresponsive to stimuli |
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal ...
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Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
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| 41 | 2021-02-21 | tenderness |
Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and ver...
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Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and very painful. The lump took over a week to soften and go away. I am still tender with some swelling in the arm pit lymph notes.
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| 41 | 2021-02-21 | feeling hot, pain |
Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary reg...
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Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
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| 41 | 2021-02-21 | pain |
deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following inj...
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deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours
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| 41 | 2021-02-22 | seizure, tingling, pain in extremity, dizziness |
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache....
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Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
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| 41 | 2021-02-22 | difficulty speaking |
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi...
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Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
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| 41 | 2021-02-22 | pain |
Started with achiness just before midnight (after having sore arm all day, but not troubling), woke ...
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Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)
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| 41 | 2021-02-22 | pain |
Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted througho...
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Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.
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| 41 | 2021-02-24 | seizure | Seizure 2 weeks later with overnight hospitalization after not having seizure since 10/2016 |
| 41 | 2021-02-28 | facial paralysis |
Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for ...
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Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 08:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included attention deficit hyperactivity disorder (ADHD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 14Jan2021 at 08:45 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced Bell's~ palsy. The event resulted in an emergency room/department or urgent care visit and received treatment which included CT scan, EKG, blood tests, and steroid prescribed. The outcome of the event Bell's palsy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-03-01 | tingling, dizziness, pain |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | pain |
Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontane...
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Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 24Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included valaciclovir hydrochloride (VALTREX). The patient previously took acetylsalicylic acid (ASPIRIN) and hydrocododone and experienced allergies. The patient experienced cold chills and aches, extreme fatigue, loss of appetite on 26Jan2021 10:00 AM. At days 5-7, my symptoms went from to strongly moderate. Fever last night (30Jan2021) of 102.3. No treatment was received for the events. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-03-02 | pain, facial paralysis |
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de...
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Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
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| 41 | 2021-03-02 | speech disorder |
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o...
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Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
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| 41 | 2021-03-02 | feeling hot, pain in extremity |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-02 | pain |
flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a sponta...
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flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 41 | 2021-03-02 | feeling hot |
heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flush...
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heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
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| 41 | 2021-03-03 | movement disorder |
headache was heavy; her body and bones felt tired; sinuses felt heavy; shoulders are heavy; her thig...
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headache was heavy; her body and bones felt tired; sinuses felt heavy; shoulders are heavy; her thigh on the back is heavy; stated that she cannot move but can walk; neck on side when she has hiccups that she feels pain and in her back; neck on side when she has hiccups that she feels pain and in her back; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the second day (Jan2021), her body and bones felt tired when she stretched and her sinuses felt heavy. On 01Feb2021, her headache was heavy. She took Benadryl. Her shoulders, neck on side and her thigh on the back were heavy on 2021. She cannot move but can walk on 2021. When she walks that it feels likes electricity. Also on 2021, her neck on side when she has hiccups that she feels pain and in her back. Patient was worried about it and wanted to know if it was normal to feel like this after the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-03-07 | tremor, dizziness |
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea...
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Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 41 | 2021-03-09 | dizziness, tingling, pain, weakness, numbness |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 41 | 2021-03-17 | dizziness, pain |
sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough;...
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sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 42 | 2020-12-31 | dizziness |
Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, co...
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Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.
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| 42 | 2020-12-31 | dizziness |
about an hour and a half after my shot Wednesday 12/30/20, I became extremely dizzy, it hit me sudd...
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about an hour and a half after my shot Wednesday 12/30/20, I became extremely dizzy, it hit me suddenly. Lasted for a few hours. 12/31/20 when I woke up, I was still light headed and slightly dizzy and I still feel the same 1/1/20 dizziness is not nearly as bad as the first day.
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| 42 | 2021-01-01 | pain in extremity |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-01 | tingling, feeling cold |
Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, L...
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Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, Left hand/wrist, Left fingertips and some on left side of face
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| 42 | 2021-01-01 | dizziness, pain |
pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy n...
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pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.
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| 42 | 2021-01-02 | dizziness |
11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patie...
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11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED. 11:54 am patient transported to hospital by EMS
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| 42 | 2021-01-02 | tremor, pain |
Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive...
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Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.
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| 42 | 2021-01-03 | swollen extremities, pain |
After patient received an injection, patient developed fever, body aches, body chills, and injection...
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After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
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| 42 | 2021-01-03 | lethargy, pain in extremity, pain |
Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. To...
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Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.
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| 42 | 2021-01-03 | dizziness | Nausea, Vomiting, extreme fatigue, dizzyness |
| 42 | 2021-01-03 | tremor |
Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for...
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Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.
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| 42 | 2021-01-03 | pain in extremity | Sore arm. |
| 42 | 2021-01-03 | numbness | arm numbness |
| 42 | 2021-01-03 | pain in extremity, pain |
began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had fin...
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began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.
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| 42 | 2021-01-04 | dizziness |
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz...
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Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
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| 42 | 2021-01-04 | weakness |
Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 4...
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Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered
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| 42 | 2021-01-04 | pain |
I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node...
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I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node the size of a golf ball at the base of the right side of my neck that lasted for 2 days, I was put on ogmentin for 5 days and it went away after that
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| 42 | 2021-01-04 | pain |
I had soreness; started with itching, redness and swelling at site of immunization.; started with it...
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I had soreness; started with itching, redness and swelling at site of immunization.; started with itching, redness and swelling at site of immunization./5.0 cm area of redness and induration; 5.0 cm area of redness and induration at site; started with itching, redness and swelling at site of immunization.; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek5730, expiry date not reported), via an unspecified route of administration on the left arm on 17Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included food allergy, oral allergy, no anaphylaxis. Concomitant medications were not reported. On 26Dec2020 18:00, the patient started with itching, redness and swelling at site of immunization. Patient also had a 5.0 cm area of redness and induration at site. Patient also had soreness on an unspecified date but no other reaction. No therapeutic measure was taken as a result of the events. Clinical outcome of pain was unknown while for the other events was not recovered. Follow-up attempts are not possible. No further information is expected.
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| 42 | 2021-01-04 | speech disorder |
Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to spe...
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Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114
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| 42 | 2021-01-04 | pain in extremity |
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of...
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Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
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| 42 | 2021-01-04 | pain, pain in extremity |
Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a...
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Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.
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| 42 | 2021-01-04 | tingling, numbness |
Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (st...
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Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)
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| 42 | 2021-01-04 | dizziness, pain in extremity, weakness |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-04 | pain | infection in L nostril and pain radiating to L eye, impacting vision |
| 42 | 2021-01-05 | pain in extremity | Sore arm and fatigue lasting 24 hours. Ibuprofen. |
| 42 | 2021-01-05 | facial paralysis | bells palsy of right eye |
| 42 | 2021-01-05 | weakness |
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ...
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she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-05 | feeling hot, tingling, numbness | tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb |
| 42 | 2021-01-06 | dizziness, feeling hot |
12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discha...
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12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
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| 42 | 2021-01-06 | feeling cold |
About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold fee...
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About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold feeling in the chest. Pt reported eating breakfast and being adequately hydrated. Patient returned to vaccine clinic, remained seated for about 30 minutes, drank water, and feeling dissipated.
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| 42 | 2021-01-06 | pain, pain in extremity |
Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sor...
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Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."
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| 42 | 2021-01-06 | pain in extremity |
Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't ...
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Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.
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| 42 | 2021-01-06 | pain | Diarrhea, nausea, Temp 102, body achestx with Ibuprofen with some relief |
| 42 | 2021-01-06 | dizziness | Dizziness, Headache, Myalgia, Fever, CoughWheeze, |
| 42 | 2021-01-06 | weakness, pain |
Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fa...
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Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique
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| 42 | 2021-01-06 | weakness |
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci...
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I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
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| 42 | 2021-01-06 | numbness | Left arm and fingers became numb for over 24hours |
| 42 | 2021-01-06 | tingling |
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re...
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Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
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| 42 | 2021-01-06 | pain |
Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a he...
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Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.
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| 42 | 2021-01-06 | weakness, numbness |
Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and s...
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Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and symptoms resolved
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| 42 | 2021-01-06 | facial paralysis |
patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left s...
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patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left side of face and cephalic region on 12/25/2020 and went to ER, where was diagnosed with Facial Paralisis
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| 42 | 2021-01-07 | pain, weakness, lethargy |
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a...
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1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
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| 42 | 2021-01-07 | tingling, dizziness, tenderness |
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint...
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3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
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| 42 | 2021-01-07 | vertigo |
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait...
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After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
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| 42 | 2021-01-07 | dizziness | BP: 120/70 - Lightheadedness, syncope. Outcome: rested, stabilized. |
| 42 | 2021-01-07 | tingling |
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -...
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Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
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| 42 | 2021-01-07 | pain, dizziness |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-07 | nerve pain |
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache le...
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Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
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| 42 | 2021-01-07 | tremor |
Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin;...
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Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
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| 42 | 2021-01-07 | dizziness, pain | Headache, Fatigue, Body Aches, Lightheaded onset day after vaccine |
| 42 | 2021-01-07 | pain in extremity |
I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a hea...
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I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a headache and full body muscles aches. I checked my temperature at 7am and it was 100.5 oral. I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am. It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.
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| 42 | 2021-01-07 | dizziness | Lightheaded and full sensation in throat 20 minutes after shot |
| 42 | 2021-01-07 | pain in extremity, pain |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECT...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | pain, pain in extremity |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTIO...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | pain in extremity, pain |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SI...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
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| 42 | 2021-01-07 | pain, feeling hot |
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o...
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Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
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| 42 | 2021-01-07 | vertigo |
When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed...
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When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed through and worked the whole shift. I was off due to the holidays for some days but symptoms did not improve. I had the vertigo and nausea for 11 days and on day 7 it prompted me to seek medical care at the clinic. The headache lasted only 2 days.
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| 42 | 2021-01-07 | vertigo |
When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the ve...
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When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the vertigo was the debilitation factor. I went to work because it was too late to call in sick, I managed to stay the whole day and then I was off some days due to the holidays. The nausea and vertigo lasted 11 days the headache lasted 2 days. I decided to go to the walk in clinic (day 7 - 12/29) because the vertigo and nausea would not go away. They run bloodwork all normal. They told me to take OTC meclizine. It took the edge off helped a tiny bit. I woke up 01/01 symptom free.
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| 42 | 2021-01-07 | pain, pain | body aches, chills, headache, fever |
| 42 | 2021-01-07 | pain |
immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to...
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immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to their emergency care area, vitals were monitored. Approx 10mins after this episode, she told them she has had this problem for the last 2 weeks. She denies shortness of Breathe or chest pain. Client was release to a family member. Her husband said she never had any other problems, except the shot made her "tired and achey". She was referred to her PCP for follow up>
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| 42 | 2021-01-07 | dizziness |
patient complained of lightheadedness, patient initially declined any juice, patient was lowered bac...
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patient complained of lightheadedness, patient initially declined any juice, patient was lowered back in recliner to wait through the 15 minute wait time. After 20 minutes patient agreed to take juice. after wait time of 30 minutes patient felt good to leave.
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| 42 | 2021-01-07 | pain, pain in extremity |
whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was...
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whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
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| 42 | 2021-01-08 | dizziness, pain in extremity |
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w...
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2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
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| 42 | 2021-01-08 | lightheadedness | Palpitations, presyncope, tachycardia, elevated blood pressure, sweating, chest pain |
| 42 | 2021-01-08 | dizziness |
Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She ...
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Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff. Vital signs were taken Temp 97.9, heart rate 84, BP 124/85. Pulse was regular. Pt denied any ongoing dizziness or other symptoms. She was given apple juice and monitored for another 15 minutes with no further symptoms
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| 42 | 2021-01-08 | pain in extremity, pain, dizziness, weakness |
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the ...
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The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
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| 42 | 2021-01-09 | pain | 1/7/2021 21:30 Headache 1/8/2021 0130 until 2330, Fever, body pain |
| 42 | 2021-01-09 | pain | Fever, chills and body aches |
| 42 | 2021-01-09 | swollen extremities |
Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enl...
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Injection site is very red, sore, and has a very large bump. Pain spread to armpit area which is enlarged and bumpy.
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| 42 | 2021-01-09 | pain |
Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted app...
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Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted approximately 5-6 hours and then started to improve.
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| 42 | 2021-01-09 | feeling hot, dizziness |
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an...
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Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
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| 42 | 2021-01-09 | weakness, tingling, pain in extremity |
Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscl...
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Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.
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| 42 | 2021-01-09 | feeling cold, pain in extremity | Sore arm, cold chills, irritable skin all over, achy muscles, headache |
| 42 | 2021-01-10 | tingling |
"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling,...
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"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling, and pain in my right shoulder and neck. It steadily progressed, and by the morning of 12/25/20, I had almost no range of motion in my neck and right shoulder, and severe pain in my right shoulder/neck/upper back area (heat/ice/ibuprofen/Aleve/Tylenol offered zero relief) . This lasted for a few days, then steadily improved until I returned to work on 12/28/20, where I had mild-moderate pain and most of my range of motion had returned. I still feel like the muscles in my neck and shoulder are tight, but I?m doing stretching exercises with heat/ice at home and it seems to be working its way out. The other symptoms were expected and mild: fever, muscle/joint aches, fatigue. These symptoms come and go ? I?ve had them since being COVID positive in March/2020. Just to be extra safe, I was swabbed for COVID on the 30th and was negative."
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| 42 | 2021-01-10 | pain |
- muscle ache in upper arm and should within first half hour of shot - extreme body aches began that...
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- muscle ache in upper arm and should within first half hour of shot - extreme body aches began that evening; continued throughout the day 1/10; still present morning of 1/11, not as intense - temperature spiked to almost 100 that evening; fluctuated throughout the next day
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| 42 | 2021-01-10 | pain |
-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache las...
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-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol
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| 42 | 2021-01-10 | pain |
1st dose 12/19/20 Symptoms 12/20/20 headache, severe body and joint pain, fever 101.0, fatigue lasti...
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1st dose 12/19/20 Symptoms 12/20/20 headache, severe body and joint pain, fever 101.0, fatigue lasting about 24hrs. 2nd dose 1/9/21 Symptoms 1/10/21 extreme fatigue, body aches, fever 100.4 duration was approximately 24hrs.
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| 42 | 2021-01-10 | dizziness |
After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and develop...
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After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20
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| 42 | 2021-01-10 | pain, pain in extremity |
Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and f...
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Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue. I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever. The night sweats continued into sunday night. I took 600mg of advil for the body aches and went to bed. When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned. Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning. I am always cold, I am the type who wears sweaters in the house all year long. For me to be that hot in the house is very unusual.
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| 42 | 2021-01-10 | pain |
Covid positive 1.11.21. Sunday after Vaccine began with headache, body aches and chills. Cough start...
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Covid positive 1.11.21. Sunday after Vaccine began with headache, body aches and chills. Cough started on Monday and full nasal congestion by Friday, 11.8.21. Covid tested Monday, 1.11.21 due to post covid vaccine questionnaire followup through workplace recommendations for covid testing. Got covid positive results about 7pm 1.11.21
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| 42 | 2021-01-10 | facial paralysis |
Facial paralysis; stress; This is a spontaneous report from a contactable Nurse. A 42-year-old femal...
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Facial paralysis; stress; This is a spontaneous report from a contactable Nurse. A 42-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter felt worried about the patient(partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of covid-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-10 | pain in extremity, pain |
Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pai...
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Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pain
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| 42 | 2021-01-10 | lightheadedness | Headache, chest pain, fatigue, feeling of near syncope |
| 42 | 2021-01-10 | pain |
I was really fatigue, and I felt feverish. I checked my temp and it was greater than 104, I was unab...
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I was really fatigue, and I felt feverish. I checked my temp and it was greater than 104, I was unable to go to work. My hips hurt and some body ache and taking aspirin.
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| 42 | 2021-01-10 | feeling hot | Left axilla pain, left outer arm red, hot, firm. |
| 42 | 2021-01-10 | difficulty speaking |
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi...
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Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
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| 42 | 2021-01-10 | migraine, facial paralysis |
Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergenc...
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Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-11 | pain |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | dizziness | Developed scratchy throat 15 min after shot, dizzy and sent to ED per MD |
| 42 | 2021-01-11 | pain, dizziness | Dizziness for 4 days vomiting body aches and severe diarrhea |
| 42 | 2021-01-11 | weakness | Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness. |
| 42 | 2021-01-11 | pain, dizziness | Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue |
| 42 | 2021-01-11 | migraine |
Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense e...
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Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense enough for me to have to call off sick from work on Friday.
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| 42 | 2021-01-11 | dizziness | Nausea, dizziness, fatigue, constipation, lower back pain. |
| 42 | 2021-01-11 | pain |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccin...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccine, visit with PCP who prescriped 800mg ibuprofen 3x/day and rest, no work. Symptoms began 7am on 1/9/21. Fever, chills, headaches, body aches . symptoms began 9am on 1/9/21 and lasted 24 hours. utilized tylenol to control fever. Low grade fever until 3pm on 1/10/21 - more than 24 hours after symptoms began
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| 42 | 2021-01-11 | pain, swollen extremities |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, ...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, had a PCP visit in clinic, off work for 3 days and prescribed anti-inflammatory. Fever, aches, chills, headaches, began 1/9/21 at 9am. Resolved within 24 hours. used tylenol as bottle dosage. Low grade fever until 1/10/21 at 3pm. used aleve as bottle dosage.
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| 42 | 2021-01-11 | pain |
The day after the 2nd dose, I experienced mild side effects of chills, body aches and fatigue that l...
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The day after the 2nd dose, I experienced mild side effects of chills, body aches and fatigue that lasted approximately 4 hours.
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| 42 | 2021-01-11 | dizziness |
Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken ...
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Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.
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| 42 | 2021-01-11 | pain |
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa...
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Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
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| 42 | 2021-01-11 | numbness, tingling |
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face...
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Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.
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| 42 | 2021-01-11 | pain |
Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills an...
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Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills and fever 100.4.
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| 42 | 2021-01-11 | feeling hot |
became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms reso...
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became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms resolved and colleague returned to department to resume work. Symptoms re-occurred
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| 42 | 2021-01-11 | vertigo |
joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; develo...
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joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 42 | 2021-01-12 | numbness, pain in extremity |
1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted thro...
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1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.
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| 42 | 2021-01-12 | tingling |
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation st...
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10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
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| 42 | 2021-01-12 | pain in extremity |
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ...
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1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
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| 42 | 2021-01-12 | pain, speech disorder, tingling |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | pain in extremity |
About ten minutes after administration I began to feel prickly, burning on my arms which gradually g...
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About ten minutes after administration I began to feel prickly, burning on my arms which gradually got worse over the next 20 minutes and spread to my hands, sides, back and legs. Arms were very red. Informed clinic medical provider who took vitals. blood pressure was 186/116 o2 sat were normal. was given an im shot of benedryl and water, vitals were continued to be monitored and blood pressure came down to 145/84. Prickly burning sensation and redness continued. Went home and examined body and did have several hives on back and upper arm. slept due to benedryl, woke up to a very sore arm, achy joints but the prickly burning had mostly resolved. next day still feel tired and achy in joints but burning is gone.
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| 42 | 2021-01-12 | pain |
Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report f...
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Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | pain |
Headache; Mental foggy; body aches; tired; This is a spontaneous report from a contactable Nurse (pa...
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Headache; Mental foggy; body aches; tired; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in right arm on 06Jan2021 H 05:00 PM at single dose for COVID-19 immunization, lot number: EL3246. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included Antibiotic. On 07Jan2021 at 09:00 AM patient experienced headache, mental foggy, body aches and tired. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events at the time of the report. No follow up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | dizziness | Nausea, dizziness, chills, headache |
| 42 | 2021-01-12 | tingling |
Patient initially experienced tingling in left hand right after injection. This resolved but then sh...
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Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
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| 42 | 2021-01-12 | inability to speak, pain in extremity |
Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficul...
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Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficulty coming up with words to use Exhaustion
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| 42 | 2021-01-12 | pain in extremity |
Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid posi...
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Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid positive via PCR swab.
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| 42 | 2021-01-12 | pain | chills, fever,body aches,headace,nausea |
| 42 | 2021-01-12 | pain |
fatigue; headache; body aches; This is a spontaneous report from a contactable healthcare profession...
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fatigue; headache; body aches; This is a spontaneous report from a contactable healthcare professional reporting for a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0142), intramuscular on 04Jan2021 15:30 in left arm at single dose for COVID-19 immunization. Medical history included COVID-19, type 1 diabetes and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included insulin. The patient experienced fatigue, headache and body aches on 05Jan2021 10:00. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 42 | 2021-01-12 | pain, weakness | weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet |
| 42 | 2021-01-13 | pain | 15 hrs after injection severe body aches, chills, muscle and joint pain. Lasted 24 hrs. |
| 42 | 2021-01-13 | feeling hot, dizziness |
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e...
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1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
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| 42 | 2021-01-13 | pain | Body aches, insomnia |
| 42 | 2021-01-13 | tremor |
Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone...
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Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.
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| 42 | 2021-01-13 | weakness |
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st...
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Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
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| 42 | 2021-01-13 | pain, dizziness | Lightheaded, body aches. Resolved |
| 42 | 2021-01-13 | dizziness, weakness |
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g...
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Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
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| 42 | 2021-01-13 | pain in extremity |
Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is o...
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Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is on the right side. No other findings
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| 42 | 2021-01-13 | dizziness, dizziness | Systemic: dizzy and bp high 149/95 |
| 42 | 2021-01-13 | numbness |
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (...
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Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
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| 42 | 2021-01-13 | tingling, numbness, lightheadedness |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | pain | body ache, headache. called in sick to work. |
| 42 | 2021-01-13 | pain |
chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous...
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chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous report from a contactable other health professional (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 02Jan2021 11:00 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. Allergies to medications, food, or other products was no. Concomitant medication included escitalopram oxalate (LEXAPRO, 10 mg) and vitamins nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient experienced symptoms chills, body ache, mild headache, fatigue, and upper chest discomfort with deep breath on 06Jan2021. Patient never had a fever. Symptoms were resolved by the next day (07Jan2021). No treatment was received for the events. All events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-13 | dizziness, pain in extremity |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-13 | difficulty speaking |
reported hoarseness in the voice; itching and burning sensation around the throat; shortness of brea...
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reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.
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| 42 | 2021-01-14 | pain |
-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprof...
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-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue
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| 42 | 2021-01-14 | feeling hot |
10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breath...
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10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved. Within the hour, symptoms resolved and patient returned to work
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| 42 | 2021-01-14 | pain |
2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those e...
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2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those effects went away low grade fever, aches, but had a knot axillary lymph node, and my arm hurt worse then the swelling spread to my chest and neck. No trouble breathing. I went to the ER because the swelling was getting worse and they did a CT scan and gave me IV fluids. The CT scan revealed swollen lymph nodes.
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| 42 | 2021-01-14 | pain, tingling, lightheadedness |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | tingling, lightheadedness |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | tenderness |
After normal soreness at the injection site, she started with tenderness under in the axillary area....
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After normal soreness at the injection site, she started with tenderness under in the axillary area. States no change in skin; however, is tender to palpate or to have clothes rubbing
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| 42 | 2021-01-14 | feeling hot, dizziness | After second vaccine: light-headed, chills, hot, muscle aches, headache, light feeling |
| 42 | 2021-01-14 | tingling, numbness | Burning , tingling of arm down to left leg. Burning on back of torso. Numbness down left arm and leg |
| 42 | 2021-01-14 | pain |
Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted ...
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Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs; This is spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on the left arm first dose on 16Dec2020 06:00 (lot number: EK57303121) and second dose on 07Jan2021 16:45 (lot number: EL3246) at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 08Jan2021 05:00 AM, the patient experienced chills, body aches, nausea, vomiting, fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs. No treatment was received for the events chills, body aches, nausea, vomiting. The events resulted to a doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies to medications, food, or other products. Outcome of the events was recovering.
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| 42 | 2021-01-14 | pain |
Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is...
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Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 06Jan2021 14:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme Headache, chills, sore throat, water eyes, runny nose, tiredness entire body aches on 07Jan2021. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19, the patient underwent lab tests and procedures which included Covid-19 test/Nasal Swab: negative on 05Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-14 | pain |
I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 wit...
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I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 with severe body aches, cold sweats and shivering. It was hard to walk the body aches were horrible. I checked my temp and it was 100.3 F
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| 42 | 2021-01-14 | numbness |
I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had ...
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I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had a pretty big immune response. the right side of my face got numb into my neck and my chest and I feel my lymph nodes turned into marbles. I also have swelling in my lymph nodes, my neck and my back. I sought medical care on Thursday due to the swelling and my PCP does not have a clue what to do.
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| 42 | 2021-01-14 | pain |
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that...
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Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
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| 42 | 2021-01-14 | pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and h...
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Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and headache around 10am 1/12. Cough and fever developed by 4pm 1/12, cough was mild and fever never exceeded 101 degrees Fahrenheit. Also experienced fatigue and body aches. Nausea successfully treated with promethazine. All symptoms dissipated significantly or gone altogether around 1am 1/13.
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| 42 | 2021-01-14 | pain |
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. O...
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Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment. Will continue to monitor.
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| 42 | 2021-01-14 | pain in extremity | SORE ARM |
| 42 | 2021-01-14 | tenderness | Swelling red tender and very itchy. |
| 42 | 2021-01-14 | lightheadedness | Vaso vagal response. No LOC. No additional medical treatment required. |
| 42 | 2021-01-14 | numbness |
from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and s...
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from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and started driving home I began to notice that my face was slightly numb (Iike I'd had too much novicaine). This was maybe 20-25 minutes after the dose. When I was home I also noticed that the back of my throat felt a little swollen. This probably lasted for a couple hours.
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| 42 | 2021-01-14 | pain | having flu like symptoms including fatigue, body aches, limb heaviness |
| 42 | 2021-01-15 | dizziness | Dizziness, nausea |
| 42 | 2021-01-15 | pain | Fever 101.8 Headache Pain behind eyes Aches Chills |
| 42 | 2021-01-15 | tremor, pain |
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh...
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Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
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| 42 | 2021-01-15 | dizziness, tingling, pain in extremity, pain, numbness, feeling hot, feeling cold |
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl...
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Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
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| 42 | 2021-01-15 | pain |
chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and ne...
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chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and neck/chest
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| 42 | 2021-01-16 | numbness, tingling, pain in extremity |
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I...
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"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
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| 42 | 2021-01-16 | dizziness, lethargy, pain |
1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/202...
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1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/2021 Muscle spams (neck) - body ached, lethargy - Took Tylenol 1/12/2021 Headache (sinus pressure) started fading at around 8 pm 1/13/2021 Lightheaded 1/14/2021 Lightheaded 1/14/2021 back to normal
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| 42 | 2021-01-16 | dizziness, swollen extremities, pain in extremity, weakness |
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor...
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Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
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| 42 | 2021-01-17 | numbness, tingling, weakness, nerve pain |
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind...
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couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-17 | dizziness |
difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nur...
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difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation. Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-19 | numbness, involuntary muscle movements |
About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throa...
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About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post. I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.
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| 42 | 2021-01-19 | numbness, bell's palsy |
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting...
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EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
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| 42 | 2021-01-19 | pain | Fever, chills, body aches |
| 42 | 2021-01-19 | dizziness | Heart was racing and lightheadedness |
| 42 | 2021-01-19 | weakness, pain in extremity |
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid...
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Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
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| 42 | 2021-01-19 | weakness |
Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 tha...
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Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 that lasted around another 20 hours. Muscle aches, weakness, fatigue and decreased appetite for duration of fever. Took excedrin for severe headache once fever broke. Symptoms completely resolved 12h later, after sleeping.
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| 42 | 2021-01-19 | migraine |
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until...
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Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
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| 42 | 2021-01-19 | pain |
PERSISTENT BODY ACHES, HEADACHES AND CHILLS LASTING FROM AROUDN MIDNIGHT THROUGH MOSST OF THE FOLLOW...
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PERSISTENT BODY ACHES, HEADACHES AND CHILLS LASTING FROM AROUDN MIDNIGHT THROUGH MOSST OF THE FOLLOWING DAY, EASING OFF IN THE EVENING. TEMP AS HIGH AS 99.3. HEATING PAD TO LOWER BACK, ONE EXTRA STRENGTH TYLENOL TAKE ~4 HRS AFTER ONSET OF SYMPTOMS.
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| 42 | 2021-01-19 | pain, pain in extremity |
When went from sitting to standing position noticed pain/numbness on bottom of left foot. When wen...
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When went from sitting to standing position noticed pain/numbness on bottom of left foot. When went to walk, pain shot up through foot with each step, making it difficult to walk. This lasted for approximately 35 feet before resolving.
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| 42 | 2021-01-19 | dizziness, pain in extremity |
arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treat...
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arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treated with ibuprofen, Tylenol, Zofran which has helped some, but all comes back and now for 2 weeks.
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| 42 | 2021-01-19 | weakness, vertigo |
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov...
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within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
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| 42 | 2021-01-20 | facial paralysis |
Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyeli...
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Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyelid, mouth, decreased salivary secretion, facial, ear, mastoid pain. Started prednisone 60mg daily and Acyclovir 400mg po 5x/day on 1/17/2020 x 1 week course. No improvement since onset.
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| 42 | 2021-01-20 | pain |
Fever; body pain; Headache; This is a spontaneous report from a contactable Nurse (patient). This 40...
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Fever; body pain; Headache; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 07Jan2021 07:30 A.M. on Arm left at single dose (Lot # EL1283) for covid-19 immunisation. No other vaccine in four weeks. Medical history included Thyroid Cancer. None known allergies. No COVID prior vaccination. Concomitant medications included Levothyroxine and ubrogepant (UBRELVY). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 18Dec2020 04:00 P.M. on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient experienced headache started the day of 07Jan2021 at 21:30. Fever and body pain 08Jan2021 01:30 until 23:30. Lab data included Nasal Swab and COVID PCR on 08Jan2021: all Negative. No treatments were received. Outcome of the event headache was recovered. Outcome of the events Fever and body pain was recovered on 08Jan2021 23:30. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-20 | pain, pain in extremity, weakness |
pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and ...
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pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 42 | 2021-01-21 | pain in extremity, swollen extremities, pain |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-21 | pain, dizziness | Body aches, chills, headache, dizziness, ringing in the ears, nausea, vomiting, and fatigue |
| 42 | 2021-01-21 | pain |
Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of...
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Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.
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| 42 | 2021-01-21 | pain in extremity, tenderness |
Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axill...
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Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axilla/ breast, tenderness soreness to left brachial inner elbow up left bicep into axilla
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| 42 | 2021-01-21 | tremor |
Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medi...
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Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medium
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| 42 | 2021-01-22 | tingling, pain in extremity |
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg...
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At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
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| 42 | 2021-01-24 | tremor, pain |
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec...
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12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
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| 42 | 2021-01-24 | pain, pain in extremity |
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to sho...
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Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches. Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
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| 42 | 2021-01-24 | dizziness, tremor |
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable c...
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Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 42 | 2021-01-24 | pain in extremity |
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ...
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No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
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| 42 | 2021-01-24 | numbness |
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m...
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Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
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| 42 | 2021-01-24 | pain, migraine |
Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I...
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Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.
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| 42 | 2021-01-24 | dizziness, feeling hot |
Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, he...
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Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
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| 42 | 2021-01-24 | tingling, facial paralysis, pain, numbness, pain in extremity |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-24 | pain |
reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started havin...
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reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started having chills, body aches, HA. On Saturday,- fever and chills, body aches, HA. Reports on Sunday she felt slightly better, but still some s/s. Today 1/25: reports she feels flushed and HA still present.
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| 42 | 2021-01-25 | dizziness |
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tig...
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1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
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| 42 | 2021-01-25 | pain |
At the time of injection, after 5 minutes she had muscle pain from what she thought was the vaccine....
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At the time of injection, after 5 minutes she had muscle pain from what she thought was the vaccine. By noon, she could not move her arm. That did not subside until 4 days later. Day 5 it still hurt but was getting better. She reports she is still not sleeping well at night. She said she can barely put her sports bra on or pull up her pants without it hurting. She did try Motrin, and it helped with the throbbing pain but not with her range of motion. Ice does help a little bit.
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| 42 | 2021-01-25 | pain |
My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then abou...
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My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then about a week later i started just itching on my for arms and torso. I have little bumps and they itch. It comes and goes.
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| 42 | 2021-01-25 | pain |
Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100...
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Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100.3 F; This is a spontaneous report from a contactable nurse reported for herself. A 42-years-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 14Jan2021 10:00 at single dose on left arm for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), clonazepam (KLONOPIN), quetiapine fumarate (SEROQUEL), aspirin [acetylsalicylic acid] (ASPIRIN). The patient received first dose of COVID 19 for covid-19 immunisation at 42-years-old, lot unknown=False, administration date=on 24Dec2020 09:00 AM, administrator route=Intramuscular, vaccine location=Left arm. The patient experienced woke up at 01:00 with severe body aches, was hard to walk or move, cold sweats, chills, fever of 100.3 f on 15Jan2021 13:00. Lab data included body temperature 100.3 f on 15Jan2021 13:00. The event outcome was recovering. No treatment was received for the adverse event. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 42 | 2021-01-25 | pain |
Woke up in excruciating pain; Fever; Joint and muscle pain; Joint and muscle pain; This is a spontan...
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Woke up in excruciating pain; Fever; Joint and muscle pain; Joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 21Dec2020 04:00 PM at a single dose on left arm for COVID-19 immunization. On Tuesday morning, 12Jan2021, patient woke up in excruciating pain. She had fever, joint and muscle pain. The outcome of the events was recovering. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 42 | 2021-01-26 | weakness |
DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK ...
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DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK 5 DAYS TO RESOLVE. WAS PRESCRIBED AN INHALER BY PCP (UNSURE WHAT IT WAS)
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| 42 | 2021-01-26 | tingling |
Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1...
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Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1 GM tablet TID
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| 42 | 2021-01-26 | pain, weakness, pain in extremity |
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Sti...
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Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
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| 42 | 2021-01-26 | pain in extremity, numbness, tingling |
While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face ...
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While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face began to feel numb and tingly. I immediately took Benadryl when I arrived home and had no further facial symptoms. However, approximately 23 hours post vaccination I developed a fever of 102 and chills that lasted approximately 6 hours. After the fever broke, I have had no further symptoms other than a sore arm and have not missed any work.
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| 42 | 2021-01-26 | tingling, speech disorder |
heart started to race; tingling sensation from her left arm that radiated to all over her body to th...
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heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-28 | dizziness, pain |
1/28/21 5am headache and dizzy, 1/28/21 7am whole body aches, fatigue, unable to get warm. Tried to ...
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1/28/21 5am headache and dizzy, 1/28/21 7am whole body aches, fatigue, unable to get warm. Tried to sleep and drink water throughout the day. 1/29/21 7am woke up feeling better with just a massive headache.
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| 42 | 2021-01-28 | dizziness, lightheadedness |
Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnanc...
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Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged
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| 42 | 2021-02-01 | facial paralysis | After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke |
| 42 | 2021-02-01 | dizziness |
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse...
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I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
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| 42 | 2021-02-01 | facial paralysis |
facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-y...
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facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated. Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 42 | 2021-02-07 | dizziness, feeling hot |
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi...
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blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-02-08 | unresponsive to stimuli, inability to speak |
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous...
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anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-14 | tenderness, weakness | developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0. |
| 42 | 2021-02-14 | pain in extremity |
woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all...
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woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-17 | pain in extremity, dizziness, pain |
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ...
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smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
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| 42 | 2021-02-18 | dizziness |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | tenderness, migraine, pain in extremity |
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i...
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Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
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| 42 | 2021-02-21 | dizziness | Palpaltations and dizziness |
| 42 | 2021-02-21 | pain, tingling |
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February...
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Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. Â At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. Â She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. Â Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. Â She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. Â No known history of allergy to polyethylene glycol. Â No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. Â She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. Â She denies any recent medication changes or new over-the-counter medications. Â She has not previously been diagnosed with COVID-19.
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| 42 | 2021-02-22 | dizziness |
Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light he...
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Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light headed. BP 142/98, P 100 at 10:16am. Placed on floor with head down/feet elevated. Ice packs applied to neck. Given water to drink. Monitored for 30 minutes with no improvement. BP 112/80 P 80 @ 10:46am. Squad called to transport to ER.
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| 42 | 2021-02-22 | dizziness |
I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as...
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I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower. I came to, rested a second but when he helped me up I fainted a second time. Laid in bed for several hours. Took blood pressure/heart rate around noon and heart rate was 115.
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| 42 | 2021-02-22 | dizziness |
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ...
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Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
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| 42 | 2021-02-22 | pain | Second vaccine 02/19/2021 1150, first vaccine 01/29/2021@1150; Headache, aching and vomited once |
| 42 | 2021-02-22 | weakness | Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High |
| 42 | 2021-02-23 | tremor |
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue...
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anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-23 | pain, tingling |
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that...
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per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
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| 42 | 2021-02-24 | tingling |
Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-ye...
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Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 42 | 2021-02-24 | weakness, dizziness, pain |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | numbness, tingling |
tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by ti...
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tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine). The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
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| 42 | 2021-02-25 | numbness, tingling |
Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneou...
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Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), via an unspecified route of administration at the right arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included carbamazepine and quetiapine. On 01Feb2021 16:00, the patient experienced face numb and tingly for several hours. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date in Feb2021.
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| 42 | 2021-02-25 | dizziness, speech disorder |
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff...
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felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
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| 42 | 2021-02-28 | dizziness |
light headed and dizzy, mild; This is a spontaneous report from a contactable consumer (patient). A ...
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light headed and dizzy, mild; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first single dose of BNT162B2 (Pfizer, solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Feb2021 10:30 to 11Feb2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced light headed and dizzy, mild; lasted day of injection on 11Feb2021 16:00. The event was considered as non-serious by the reporter. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from the event on an unspecified date in Feb2021.
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| 42 | 2021-03-02 | pain |
I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than...
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I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated "I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 42 | 2021-03-05 | tingling |
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, a...
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Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
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| 42 | 2021-03-14 | numbness, pain in extremity, dizziness, weakness |
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo...
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unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-03-18 | tenderness |
left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; Thi...
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left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 42-years, via an unspecified route of administration in left arm on 31Jan2021 at single dose for COVID-19 immunization, in workplace clinic. Medical history included shell-fish allergy. No other vaccine in four weeks, no COVID-19 prior vaccination. Patient was tested negative for COVID-19 virus test (Nasal Swab) on 25Jan2021. No other medications in two weeks. At 00:00 on 17Feb2021 (16Feb2021 12:00 PM), the patient experienced left arm was tender and muscles were sore on the left side. Cramping feeling and feels like spasms. Patient went to the hospital cause of pain. The adverse events resulted in emergency room/department or urgent care. No treatment. On an unspecified date, COVID-19 was tested post vaccination with unknown results. Outcome of the events was unknown.
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| 42 | 2021-03-21 | pain |
Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the...
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Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.
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| 43 | 2021-01-02 | dizziness | Racing heart, dizziness, lightheadedness |
| 43 | 2021-01-02 | tenderness |
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for...
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Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
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| 43 | 2021-01-03 | pain in extremity | ACHINESS TO LEFT ARM. 7 HOURS AFTER RECEIVING VACCINE EXTREMELY PAINFUL WITH DECREASE ROM. |
| 43 | 2021-01-03 | dizziness |
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post inje...
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Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
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| 43 | 2021-01-03 | pain |
Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration ...
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Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration and lasted about 8 hours.
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| 43 | 2021-01-03 | pain in extremity |
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but...
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My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
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| 43 | 2021-01-03 | migraine |
On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea...
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On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
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| 43 | 2021-01-03 | tingling, dizziness, feeling hot | Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint. |
| 43 | 2021-01-03 | nerve pain, numbness, facial paralysis |
Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I ha...
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Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
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| 43 | 2021-01-03 | pain |
She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spin...
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She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-03 | pain in extremity | patient developed arm pain day after vaccination that lasted about 1 day. |
| 43 | 2021-01-04 | dizziness |
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; Abo...
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About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | pain in extremity |
Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43...
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Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 30Dec2020 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 13:30, the patient experienced arm pain. No treatment was provided for the event arm pain. The outcome of the event arm pain was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | dizziness | Dizziness, nausea, light headedness, palpitations |
| 43 | 2021-01-04 | pain |
Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen t...
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Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).
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| 43 | 2021-01-04 | feeling hot |
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned...
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Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | seizure |
The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twi...
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The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twice a day, on the second day after vaccination developed recurrent seizures requiring hospitalization to an intensive care unit, with intubation and mechanical ventilation until 1/5/21 (to be extubated today). She is still at the hospital.
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| 43 | 2021-01-04 | pain in extremity |
arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A...
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arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain/soreness on unspecified date. The outcome of the event arm pain/soreness was unknown. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-04 | feeling hot |
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ...
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fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
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| 43 | 2021-01-04 | pain in extremity |
sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I cou...
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sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
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| 43 | 2021-01-05 | dizziness |
1815: pt complained mild dizziness, O2:97 %, BP: 115/83, HR: 86, pt given 50 mg Benadryl orally, ate...
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1815: pt complained mild dizziness, O2:97 %, BP: 115/83, HR: 86, pt given 50 mg Benadryl orally, ate some almonds and chips, not redness or swelling at site 1830: pt stated she was feeling better, requested to go home
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| 43 | 2021-01-05 | numbness |
I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numb...
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I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numbness was constant all day and around 4 pm that same day I developed right forearm numbness. On Jan 5th the symptoms have seemed to have resolved in my legs, right forearm is still slightly numb. No weakness present just numbness.
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| 43 | 2021-01-05 | dizziness, pain |
I have been experiencing body ache throughout my whole body, pain if stay in one position to long on...
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I have been experiencing body ache throughout my whole body, pain if stay in one position to long on right hip or lower; headaches; I experienced dizziness, felt giddy/light headed; Then at night my whole body felt sore, ached on lower back and right side of my hip; Then at night my whole body felt sore, ached on lower back and right side of my hip; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm) on 29Dec2020 at 07:30 AM, at a single dose, for COVID-19 immunization. The patient has no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. Patient did not receive other vaccine four weeks prior COVID vaccination. The patient did not have COVID prior vaccination. The vaccine was administered in the hospital. Same day of shot, the patient experienced dizziness, felt giddy, then at night her whole body felt sore, ached on lower back and right side of her hip. In the morning of 30Dec2020, patient experienced body ache throughout my whole body, pain if stay in one position to long on right hip or lower back and legs, light headed and headaches. The patient did not receive treatment for the events. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.
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| 43 | 2021-01-05 | tingling |
Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamet...
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Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved
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| 43 | 2021-01-05 | dizziness | Pt reported itchiness to her body and dizziness. |
| 43 | 2021-01-06 | pain | Body aches and chills, no fever. Felt poorly. Sent home from her shift. |
| 43 | 2021-01-06 | dizziness |
Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl gi...
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Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl given at 1614. 1615 Epi in L thigh. Pt transported to ED by wheelchair
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| 43 | 2021-01-06 | pain in extremity |
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil...
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First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
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| 43 | 2021-01-06 | pain in extremity |
Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection f...
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Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection for a few days
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| 43 | 2021-01-06 | tingling, numbness, pain in extremity |
I initially developed left arm soreness in the evening of administration of the injection. The follo...
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I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg. Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.
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| 43 | 2021-01-06 | pain |
Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down wit...
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Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain
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| 43 | 2021-01-06 | pain |
Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea ...
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Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache
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| 43 | 2021-01-06 | numbness | metallic taste, numbess tonque and left arm, no treatemnt at present |
| 43 | 2021-01-06 | pain |
report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and h...
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report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and headache with no fever which she states is tolerable at this time. There was no home remedies. continues to work and She will continue to monitor symptoms
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| 43 | 2021-01-07 | pain in extremity |
1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fe...
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1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fever of 100.4 . Treated with Tylenol and Ibuprofren. *I expected the second dose to be more 'hard hitting' then the first. The muscle / joint paint was a 6/10. 1/7 woke up at 4am and took Ibuprofren 1/8/ 'today i feel great'
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| 43 | 2021-01-07 | pain in extremity |
1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with...
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1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021 Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.
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| 43 | 2021-01-07 | dizziness |
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le...
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Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
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| 43 | 2021-01-07 | vertigo | FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION |
| 43 | 2021-01-07 | pain | Fever 101, body aches, severe headache |
| 43 | 2021-01-07 | weakness | Headache, muscle aches, weakness, low grade of fever |
| 43 | 2021-01-07 | weakness, pain in extremity | I fever 102.2 , weakness, fitage , chills, head aches and arm sores. 48 hours recovered. |
| 43 | 2021-01-07 | pain |
I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am...
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I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am. Serve headache, body aches, chill, fever. They lasted about 12 hours and then most of today just overall fatigue. I now have discomfort in my back and chest. Is this normal?
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| 43 | 2021-01-07 | numbness |
Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with va...
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Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with vaccine clinic to report symptoms and be monitored for 30 minutes.Took 50mg Benedryl. Symptoms resolved 12/28/2020.
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| 43 | 2021-01-07 | weakness |
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mi...
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Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
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| 43 | 2021-01-07 | pain |
Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm...
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Per patient report: "Received my 2nd dose Jan. 5,2021 @ 1020 noticed pain and tenderness in Left arm injection site, armpit of the same side and radiating pain across neck and shoulder to right side by the next morning Jan.6. Late afternoon pain increased in left armpit significantly and noticed swelling, warmth and hardness along with stabbing pains in left forearm and hand throughout the night. "
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| 43 | 2021-01-07 | pain | headache , body aches, fatigue, injection arm pain |
| 43 | 2021-01-07 | pain |
pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pai...
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pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.
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| 43 | 2021-01-08 | pain | Body aches severe Headache |
| 43 | 2021-01-08 | pain | Body aches, chills, slight headache |
| 43 | 2021-01-08 | pain in extremity |
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was abl...
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Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
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| 43 | 2021-01-08 | pain |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever co...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)
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| 43 | 2021-01-08 | pain |
I recievwd my 2nd dose of Pfizer Covid vaccine on 01/06/2021. I started feeling sick on 01/07/2021 e...
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I recievwd my 2nd dose of Pfizer Covid vaccine on 01/06/2021. I started feeling sick on 01/07/2021 early morning. I had a fever (ranging between 99.7 to 100.1), had chills, bodyache, and a headache. I did not have the strength to get out of bed all day (on 01/07/2021). Today my symptoms have improved to some extent but I still have a bodyache and headache.
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| 43 | 2021-01-08 | weakness |
Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours pos...
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Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).
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| 43 | 2021-01-08 | pain in extremity |
Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm ...
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Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm very regular. Not on birth control but husband has vasectomy. Chance of pregnancy is extremely unlikely. Started with bad cramping in pelvis and aching legs. Cramps have lessened. Dark blood. Brownish in color.
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| 43 | 2021-01-08 | tingling | Tingling in right arm that radiated up to cheek and eye |
| 43 | 2021-01-09 | pain |
Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after...
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Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after vaccine
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| 43 | 2021-01-09 | tingling, numbness |
Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening...
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Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening of condition and patient declined further medical care.
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| 43 | 2021-01-09 | pain |
fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. A...
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fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.
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| 43 | 2021-01-10 | pain |
Body aches, chills, sore throat, headache, low grade fever, fatigue-approximate 12 hours Alternate T...
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Body aches, chills, sore throat, headache, low grade fever, fatigue-approximate 12 hours Alternate TYL and IBU
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| 43 | 2021-01-10 | pain | Body aches, lump on arm, Fever |
| 43 | 2021-01-10 | facial paralysis, pain in extremity, numbness, tingling |
Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle ...
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Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle followed by droopy right eye and then right sided mouth drooping that comes and goes.
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| 43 | 2021-01-10 | tenderness | Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm |
| 43 | 2021-01-10 | pain |
Extreme headache, fever for 3 days from 100.0 as high as 101.8, body aches, chills, extreme fatigue(...
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Extreme headache, fever for 3 days from 100.0 as high as 101.8, body aches, chills, extreme fatigue(4 days)
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| 43 | 2021-01-10 | pain in extremity, pain |
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortne...
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Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
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| 43 | 2021-01-10 | pain |
I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:...
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I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:00 in the morning I begin to have extreme body aches causing me to wake up and my whole body was aching and I was shivering and it was difficult to move my right arm, which is the arm that took the injection. I was barely able to prop myself up to take Advil. I was down for the rest of the weekend in bed in pain. On Sunday the 10th of January the pain was less but it was more focused as a headache and I was extremely fatigued and slept the whole weekend.
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| 43 | 2021-01-10 | weakness, bell's palsy |
L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose ...
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L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose #2 of the Pfizer-BioNTech vaccine
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| 43 | 2021-01-10 | pain | Left axillary lymphadenopathy, fatigue/body aches |
| 43 | 2021-01-10 | dizziness | Left side burning. Flushed, Lightheaded, Heaviness in her Chest Tylenol |
| 43 | 2021-01-10 | pain in extremity |
Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted ...
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Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted approx. 48 hours. Motor deficit improved, but still present
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| 43 | 2021-01-10 | pain | Swelling, pain, muscle weakness, redness, heat |
| 43 | 2021-01-10 | pain | Temp 100.5, chills, body ache, fatigue |
| 43 | 2021-01-10 | vertigo | Woke and had incapacitating vertigo. I was unable to sit up without assistance and focus. |
| 43 | 2021-01-10 | pain in extremity, pain |
soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down ...
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soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-11 | pain in extremity, pain |
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07...
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1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
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| 43 | 2021-01-11 | tingling, pain |
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho...
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After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
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| 43 | 2021-01-11 | pain |
Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body a...
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Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; This is a spontaneous report from a non-contactable Other-HCP. This Other-HCP reported for a 43-year-old female patient that received second dose of bnt162b2 (BNT162B2, Pfizer COVID-19, Batch/lot number: EL0142), via Intramuscular on 05Ja2021 02:00 PM at single dose on Left arm for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products: Sulfas and first dose of bnt162b2 (COVID 19) for covid-19 immunisation. Concomitant medications were none. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Flu like symptoms like headache, chills, body aches from 05Jan202108:00 PM. No covid prior vaccination. No covid tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-11 | dizziness |
I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and sta...
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I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and started feeling woozy and seeing spots. By the time I got back into my house, I had tunnel vision and could not see directly in front of me. I went to lay down, but ran into a piece of furniture because I was so disoriented and hit my shin on it. I collapsed on my bed. I stayed there for few hours and then I was ok. I had severe, flu-like symptoms for most of the day - fever, chills, low energy, joint pain (specifically back and hip) - that waxed and waned. I finally felt almost back to normal approximately 50 hours after the injection.
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| 43 | 2021-01-11 | feeling cold |
Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM mod...
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Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.
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| 43 | 2021-01-11 | feeling hot, pain in extremity |
Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Sig...
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Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
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| 43 | 2021-01-11 | numbness, tingling |
a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand o...
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a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, "I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side" on 05Jan2021 11:30. Clinical outcome of the events was unknown.
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| 43 | 2021-01-11 | numbness |
developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness w...
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developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL1284, expiry date was unknown) via an unspecified route of administration at the left arm on 30Dec2020 09:30 AM at a single dose. for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jan2021, 6:30 pm and on 03Jan2021, the patient developed intermittent bilat lower leg numbness. On 04Jan2021, bilat lower leg numbness was constant all day and at 4pm that same day, she developed right forearm numbness. No weakness, just numbness. On 05Jan2021, leg numbness has resolved but still having slight right forearm numbness. On 06Jan2021, still no leg numbness but still having slight right forearm numbness. The events resulted in emergency room/department or urgent care. The patient recovered from the event "intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day" on 05Jan2021. Outcome of the event "developed right forearm numbness" was recovering. No treatment was performed in response to the adverse events. The events were assessed as Non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
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| 43 | 2021-01-11 | pain |
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the...
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first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
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| 43 | 2021-01-11 | pain in extremity |
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; ...
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lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 43 | 2021-01-12 | pain in extremity |
After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right a...
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After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right arm soreness which has diminished.
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| 43 | 2021-01-12 | dizziness |
Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next m...
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Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next morning she had upset stomach, feeling dizzy, thought she was going to faint and a headache.
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| 43 | 2021-01-12 | numbness, facial paralysis, tingling |
DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED M...
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DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
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| 43 | 2021-01-12 | pain, dizziness | Dizziness, full body aches, temp, headache. No treatment |
| 43 | 2021-01-12 | weakness |
Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, ex...
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Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, extreme fatigue and weakness, same duration.
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| 43 | 2021-01-12 | pain | Fever, Chills, severe body aches, sleepiness, arm soreness at injection site for about 40 hrs. |
| 43 | 2021-01-12 | tremor, bell's palsy, pain |
Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after see...
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Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after seeing PCP on Monday 01/11/2021. Patient also went back to see PCP on 01/12/2021 for follow up.
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| 43 | 2021-01-12 | pain in extremity, tenderness |
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9...
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I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
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| 43 | 2021-01-12 | tingling, numbness |
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs...
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I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
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| 43 | 2021-01-12 | weakness |
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ...
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Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
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| 43 | 2021-01-12 | pain |
Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of...
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Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of the day to the point that it was difficult to use L arm. In addition, there were diffuse body aches, chills and fatigue overnight. Chills resolved by next morning. Body aches and fatigue still present.
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| 43 | 2021-01-12 | migraine |
Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 0...
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Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 01/12/21 patient started to expereince a worsened mirgraine accompanied with vomiting and severe back pain.
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| 43 | 2021-01-12 | pain in extremity |
Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took ...
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Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took 1 aleve at 3pm. at 4pm noticed some left undereye tenderness to palpation. at 11pm noticed left undereye swelling and bruising. took zyrtec and iced. in the morning 1/10 swelling was worse. continued to ice. I contacted my dermatologist who felt it was a reaction to the previous underye filler i had >2.5 years ago. she started me on a medrol dose pack. swelling resolved by 1/11 in the morning.
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| 43 | 2021-01-12 | pain in extremity, feeling cold | Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness |
| 43 | 2021-01-12 | pain in extremity, pain, lethargy |
The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent s...
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The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent sentences. Took Tyelenol before bed because my arm was very sore. Next morning, my whole body ached and had a severe tension headache, my jaw was very tense also. I was still very lethargic and my mind still "cloudy". Took Tylenol again after dinner, that night I started to feel relief from aches, headache and my mind can think more clearly.
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| 43 | 2021-01-12 | pain |
moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in mornin...
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moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in morning at 6am.
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| 43 | 2021-01-13 | vertigo, migraine, pain in extremity |
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54...
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8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
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| 43 | 2021-01-13 | speech disorder |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | pain | Body aches, fever, headache, nausea |
| 43 | 2021-01-13 | vertigo, dizziness |
I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It to...
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I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It took me at least 30 min to feel myself. That afternoon I felt L hip pinching pains and joints pain. A week later I had sudden vertigo , unable to walk normally with no tinnitus or loss of hearing . I took meclizine 50 mg and it helped. It?s already day 5 , vertigo has subsided , I still don?t feel myself but I am able to go around, drive and move. I only feel dizzy at times and feel vertigo when laying down
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| 43 | 2021-01-13 | pain in extremity |
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a...
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I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
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| 43 | 2021-01-13 | pain |
Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, ...
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Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, esp L shoulder, L upper back, L neck, L jaw) Joint aches (whole body, esp L shoulder, L jaw) Fatigue Sharp, intermittent shooting pain in shoulder Headache Effects most pronounced night of and day after vaccine, but persisting to lesser degree still on day 3 (today)
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| 43 | 2021-01-13 | dizziness | Low grade fever, chills, headache, muscle aches and dizzy |
| 43 | 2021-01-13 | pain |
My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spont...
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My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
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| 43 | 2021-01-13 | pain |
My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body ac...
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My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body aches, and fatigue. The result of my mammogram and ultrasound confirm the swollen lymph nodes. If they are still the same in 3 months we will schedule a biopsy.
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| 43 | 2021-01-13 | dizziness |
Patient reported no contraindications at the time of prescreening and received vaccine around 1.35p...
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Patient reported no contraindications at the time of prescreening and received vaccine around 1.35pm. Around 1.38pm, patient reported of feeling dizzy, BP was taken 110/71 mmHg, at 1.46pm BP was 96/67 mmHg, at 1.57pm BP was 109/73 mmHg. After drinking water patient reported of feeling much better.
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| 43 | 2021-01-13 | weakness, tingling |
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat...
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Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
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| 43 | 2021-01-13 | feeling cold |
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at a...
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Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
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| 43 | 2021-01-13 | pain, pain |
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on...
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We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
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| 43 | 2021-01-13 | pain in extremity |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | pain | fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent |
| 43 | 2021-01-13 | pain in extremity | headache, chills, fever, sore arm, fatigue |
| 43 | 2021-01-14 | tingling, dizziness |
1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and...
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1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and related she was feeling much better
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| 43 | 2021-01-14 | dizziness |
12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, ...
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12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms. Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
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| 43 | 2021-01-14 | tingling |
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in ...
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15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
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| 43 | 2021-01-14 | dizziness |
Dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old fe...
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Dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 17:00 at a single dose for COVID-19 immunization. The patient received her first dose of bnt162b2, via an unspecified route of administration on the left arm on 19Dec2020 at 13:00. Both doses were administered at the hospital. The patient had no medical history. The patient had no known allergies; she had no allergies to medications, food, or other products. Concomitant medication included unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness on 10Jan2021 at 20:00, or 24 hours after the shot had been given. At the time of the report, at the 12 hour mark, she was still being dizzy. The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event (AE). The patient was not recovered from the event.
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| 43 | 2021-01-14 | tingling, numbness |
During 30 minute observation period patient began to have a rash across their chest consistent with ...
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During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
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| 43 | 2021-01-14 | pain, weakness | FEVER, BODY ACHES, NAUSEA, LOW APPETITE, WEAKNESS (FLU-LIKE SYMPTOMS) FOR 24 HOURS |
| 43 | 2021-01-14 | pain |
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does...
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HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
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| 43 | 2021-01-14 | pain in extremity |
Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on...
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Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
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| 43 | 2021-01-14 | pain in extremity |
Injection site soreness that developed to arm soreness with both doses.; Injection site soreness tha...
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Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
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| 43 | 2021-01-14 | pain in extremity |
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio...
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Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-14 | pain in extremity |
Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from...
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Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 12:00 in left arm at single dose for COVID-19 immunization. Medical history included hay fever, asthma, various allergies and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included progesterone, metformin, atorvastatin and metoprolol. On 05Jan202115:00, the patient experienced palm-sized discoloration around injection site and arm was very sore for two days. No treatment was given to the patient for the events. The patient recovered from the events on unspecified date. The patient underwent laboratory test which includes nasal swab: negative on 07Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch cannot be obtained.
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| 43 | 2021-01-14 | tremor |
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co...
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Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
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| 43 | 2021-01-14 | dizziness |
Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports ...
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Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports she had similar reaction when she had gotten the Hep B shot. BP 137/93 HR 92 O2 97%. RR 16. Reports history of HTN. No SOB or tightness of throat. No other symptoms. Sat for 15 more minutes. BP 133/96 HR 88. No further issues except small amount of tingling at shot sites. Patient discharged from clinic with instructions to plan for 1/2 hour sit time with next shot. Any further issues to seek care through PCP.
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| 43 | 2021-01-15 | pain, pain in extremity |
Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially lo...
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Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially low back
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| 43 | 2021-01-15 | pain | Fatigue, body aches, headache, injection site pain |
| 43 | 2021-01-15 | feeling cold, dizziness |
Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute int...
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Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.
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| 43 | 2021-01-16 | tremor, pain in extremity |
Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, t...
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Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, temp 101.3 Ibuprofen 600 mg taken. Its 3:55 temp is 101 1
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| 43 | 2021-01-16 | tingling |
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l...
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I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
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| 43 | 2021-01-16 | tremor, pain |
Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to m...
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Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking
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| 43 | 2021-01-17 | pain |
Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spon...
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Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-01-17 | dizziness |
Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachyc...
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Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.
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| 43 | 2021-01-18 | dizziness |
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy...
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Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
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| 43 | 2021-01-19 | dizziness, tingling |
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ...
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1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
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| 43 | 2021-01-19 | pain in extremity, pain |
Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less ...
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Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed
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| 43 | 2021-01-19 | pain |
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa...
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Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
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| 43 | 2021-01-19 | tremor, pain | Fever 103, chills, shaking, major body and joint aches, pain at injection site, headache |
| 43 | 2021-01-19 | numbness, pain in extremity |
Patient started feeling numbness of left hand and fingers after 10 minutes. Pain on forearm (Pressur...
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Patient started feeling numbness of left hand and fingers after 10 minutes. Pain on forearm (Pressure feeling) Patient was monitor for 15 more minutes, no other interventions
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| 43 | 2021-01-19 | pain in extremity |
Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and naus...
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Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.
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| 43 | 2021-01-19 | weakness |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-19 | pain |
back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, fi...
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back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, first dose was given on 19Dec2020; This is a spontaneous report from a contactable physician (reported for herself). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), via an unspecified route of administration (left arm) on 08Jan2021 (10:00 AM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 19Dec2020 (10:00 AM). Medical history included Celiac disease and allergies to medications, food, or other products: Latex, salicylate, wheat (celiac). Concomitant medication included melatonin (MELATONIN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that at around 30 hours after second vaccine dose (09Jan2021, 05:00 PM), the patient experienced back ache. At 36 hours post vaccine she developed intense achy and rigors and chill that lasts about 6 hours. The patient could not sleep during that time (10pm-330am). The patient took Tylenol at 1:30am. The symptoms abruptly stopped and felt perfectly fine after. There was a treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 43 | 2021-01-19 | pain, dizziness, lightheadedness |
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat...
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near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
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| 43 | 2021-01-19 | pain in extremity, dizziness |
painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated ...
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painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated from elbow up to neck and caused limited range of motion light headed, headache, severe muscle ache every joint lasting 3 days rash on torso at day 3 not itchy but red
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| 43 | 2021-01-21 | tingling, dizziness, numbness, pain | Dizziness numbness tingling body aches |
| 43 | 2021-01-21 | dizziness |
Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later t...
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Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later that day/evening patient developed rheumatoid arthritis flair up that resolved over the course of two days and use of prescription medications (diphenhydramine and prednisone). Patient has a long standing history of rheumatoid arthritis.
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| 43 | 2021-01-21 | dizziness, tingling | ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS. |
| 43 | 2021-01-21 | pain | FEVER (103.8), CHILLS, ACHY |
| 43 | 2021-01-21 | dizziness | Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy. |
| 43 | 2021-01-21 | feeling hot |
Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pi...
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Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pink. Asked to be taken to ED, stated "it could just be anxiety but I would rather be sure". Taken via wheelchair to ED immediately and placed in room on gurney. Seen by ED staff, give hydroxyzine 25mg PO at 1732. Discharged home from ED at 1847.
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| 43 | 2021-01-21 | pain | body aches fever of 101 lasted for 5 days fatigue |
| 43 | 2021-01-24 | pain |
I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand...
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I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.
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| 43 | 2021-01-24 | pain in extremity, weakness |
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose...
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Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
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| 43 | 2021-01-24 | pain in extremity, dizziness, pain |
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev...
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Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
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| 43 | 2021-01-24 | dizziness |
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato...
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Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-01-24 | pain, pain in extremity, dizziness |
Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, ...
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Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, headache. Most symptoms subsided the next day, headaches and dizziness continue daily one week later.
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| 43 | 2021-01-25 | dizziness |
As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain ...
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As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain on deep inspiration. Patient has a PMHx of anxiety which they believe instigated the side effects. Patient was transported via EMS to Palms of Pasadena hospital with non-urgent acuity.
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| 43 | 2021-01-25 | pain |
Caregiver received Dose 1 12/29/20. Her vaccination card had the previous date's sticker on it indi...
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Caregiver received Dose 1 12/29/20. Her vaccination card had the previous date's sticker on it indicating Pfizer. The 12/29/20 vaccination was distributing Moderna. Ignoring what was said to her verbally that she received Moderna and the different prompts for timing of 2nd dose, she signed up and received a Pfizer Dose 2 on 1/20/21. She developed a fever and achiness after her first Moderna administration in alignment with typical vaccine reaction. She developed similar reaction after her Pfizer second dose. She recovered fully both vaccinations after 48hrs. We disclosed this misadministration and recited the CDC guidelines to monitor and not vaccinate with a 3rd dose. Caregiver took the finding well.
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| 43 | 2021-01-25 | pain |
Chills; Body aches; Fever of 101.4; Headache; This is a spontaneous report from a contactable nurse ...
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Chills; Body aches; Fever of 101.4; Headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL7249; Expiration date was not reported), intramuscularly on the left arm, on 12Jan2021 (17:30) at a single dose for COVID-19 immunization at the hospital. Medical history included migraine headache and arthritis of knees. Concomitant medication included topiramate (TOPAMAX). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on the left arm on 22Dec2020 for COVID-19 immunization (when the patient was 43 years old). The patient was not pregnant at the time of reporting. On 13Jan2021 (12:00 AM), the patient had chills; body aches; fever of 101.4 (unit was not reported); and headache. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'fever', and 'headache', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-25 | pain in extremity, pain |
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta...
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Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-25 | dizziness |
Immediately following vaccination, the patient reported her left arm "becoming heavy", then she beca...
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Immediately following vaccination, the patient reported her left arm "becoming heavy", then she became dizzy with chest pain on deep inspiration. EMS transported patient to hospital under non-urgent acuity. Primary impression was generalized anxiety consistent with PMHx of anxiety episodes.
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| 43 | 2021-01-25 | feeling hot, pain in extremity |
Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, ha...
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Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, hard, swollen, and extremely painful; from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful.; Arm swelled up from the shoulder to the elbow and around to the inner arm; Headache; Low grade fever of 100.2F; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration in the left arm on 08Jan2021 on 15:00, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), bariatric surgery, seasonal allergies, and known allergies to bee stings, flu vaccine, and monosodium glutamate (MSG). Concomitant medications included famotidine (PEPCID) and cetirizine hydrochloride (ZYRTEC), and multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) on 17Dec2020, at 01:00 PM, in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 09Jan2021, at 14: 30, the patient's arm swelled up from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful. She also had joint pain, headache, and low-grade fever of 100.2 Fahrenheit (F). The patient did not received therapy for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-25 | pain in extremity |
Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report fro...
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Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-25 | swollen extremities |
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir...
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chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
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| 43 | 2021-01-25 | migraine, pain in extremity, pain |
headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; T...
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headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
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| 43 | 2021-01-26 | tenderness, dizziness, tingling, pain in extremity, numbness |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | tingling, numbness |
2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am o...
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2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am on suppression therapy. I have never had one since my initial diagnosis. I also began having numbness and tingling in both feet and hands. The symptoms continued through the second vaccine dose on January 16. The numbness and tingling in my extremities has become worse. An increased dose of Valacyclovir has been ineffective in treating the HSV outbreak symptoms.
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| 43 | 2021-01-26 | feeling of body temperature change |
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick...
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Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
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| 43 | 2021-01-26 | pain | Fatigue, chills, high fever(101.4), body aches, diarrhea, headache-lasted 24 hours and still going |
| 43 | 2021-01-26 | numbness |
I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, howe...
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I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, however my symptoms did start within 72 hours of receiving the vaccination. As of today, my symptoms remain, but seem to be improving.
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| 43 | 2021-01-26 | difficulty speaking |
Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous ...
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Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | pain |
Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 2...
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Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours
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| 43 | 2021-01-26 | pain |
Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and bod...
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Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and body aches. Day 3 still had some body aches. Day 4 the pt returned to feeling normal.
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| 43 | 2021-01-26 | pain |
a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is ...
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a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140, expiry date: 31Mar2021) intramuscular on left arm (left deltoid) single dose for COVID-19 immunization on 21Dec2020, 10:20 am, at 43-year-old. No medical history, drug allergies and family history. Concomitant medication included: multivitamins (unspecified) daily whenever she remembered to take them. The patient had no issues with that vaccination, maybe a little tiredness and achiness the next day (22Dec2020), but no reactions, no asthma, anaphylaxis or anything. Had a CBC, CMP, and 2 chest x-rays and they were all normal. The patient was not deceased. Relevant tests included: CBC, CMP and twice Chest X-ray; all with normal results. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
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| 43 | 2021-01-26 | dizziness, pain in extremity |
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her...
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hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
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| 43 | 2021-01-27 | pain in extremity |
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccin...
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Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.
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| 43 | 2021-01-27 | vertigo, dizziness, pain |
Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nau...
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Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-28 | pain |
About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body ac...
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About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body aches impairing my ability to work.
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| 43 | 2021-01-28 | pain in extremity |
Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort,...
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Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort, gases and diarrhea,
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| 43 | 2021-01-28 | tingling |
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report...
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Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
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| 43 | 2021-01-28 | pain in extremity |
Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. ...
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Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. Unknown is knot is hematoma, abscess or cellulitis at injection site. Symptoms started x 24 hours after injection. Arm was sore after shot but knot developed approximately 24 hours later.
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| 43 | 2021-01-28 | pain |
Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Ache...
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Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Aches, Fatigue all over starting 24 hours after receiving vaccine. Lasted for about 8 hours. Fully recovered by next morning.
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| 43 | 2021-01-28 | weakness, dizziness |
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ...
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Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
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| 43 | 2021-02-02 | numbness, dizziness |
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi...
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felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-02-07 | dizziness, lethargy |
Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:9...
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Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92
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| 43 | 2021-02-10 | pain, weakness | Headache, chills, body aches, Muscle pain, weak, sweats |
| 43 | 2021-02-21 | dizziness | Dizziness at time of injection |
| 43 | 2021-02-21 | pain in extremity |
On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on...
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On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
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| 43 | 2021-02-21 | dizziness, pain in extremity |
Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. res...
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Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.
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| 43 | 2021-02-22 | facial paralysis | Drooping eye and mouth on left side of fave |
| 43 | 2021-02-22 | dizziness | Tightness in left arm immediately; dizziness - 2 hrs later; significant diarrhea from 8pm - 4am. |
| 43 | 2021-02-22 | facial paralysis, bell's palsy, pain |
Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours...
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Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours. Approximately 40 hours after injection, noticable drooping of right side of face, which resolved 90% after 24 hours; doctor assessment was that this was likely a temporary case of Bell's Palsy.
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| 43 | 2021-02-22 | feeling hot |
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and f...
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at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
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| 43 | 2021-02-22 | numbness |
numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; ...
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numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-02-23 | weakness, tremor, pain, lethargy |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-23 | pain | Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe |
| 43 | 2021-02-24 | dizziness, tremor |
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt lik...
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About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day
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| 43 | 2021-02-25 | weakness, dizziness |
Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spon...
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Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.
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| 43 | 2021-02-25 | pain |
swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't co...
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swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
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| 43 | 2021-02-28 | lightheadedness |
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have...
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she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-03-01 | dizziness |
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous rep...
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heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
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| 43 | 2021-03-03 | numbness, pain |
eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbne...
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eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbness on left side of my face, I was taken to the ER, it went down to the left side of my neck and my left arm, after an hour I couldn't move the entire left side of my body, they did an MRI and admitted me to overnight observation. next morning I was discharged (friday), physical therapy and occupational therapy came in to help me adjust because I was still numb I was given a walker and a knee brace, I went home. Saturday I started getting feeling in my face and neck. Sunday I was still gaining more sensation, Monday I had full sensation every where except my leg, Tuesday I had complete feeling on my entire left side. 7 days after my shot on wednesday I started having cold chills body aches and fever nausea and diarrhea, by thursday I couldn't eat anything in me I would have diarrhea. I went to the ER on Saturday, they ran tests CT scan and found entera colitis and was admitted again, they started me on iv antibiotics and fluids , no solid food, they tested my stool and everything came back normal. I was discharged because the diarrhea had stopped, I was having regular bowl movements. Dr said it may or may not have been a cause from the vaccine, they weren't sure.
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| 43 | 2021-03-08 | numbness |
Patient had numbness in the left leg, few minutes after vaccine administration. The numbness disappe...
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Patient had numbness in the left leg, few minutes after vaccine administration. The numbness disappeared 30 minutes after she made the complaint. We monitored her further for another 30minutes, and she was fine, so no further intervention.
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| 43 | 2021-03-09 | dizziness | Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness |
| 43 | 2021-03-09 | pain in extremity, facial paralysis |
tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable ...
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tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at left arm 23Feb2021 08:00 at single dose for covid-19 immunisation. Medical history included Known allergies: Sulfa drugs, codeine, diastolic dysfunction type 1 from Jul2020, and anxiety depressive disorder (she took a medication for that and it had been diagnosed more than ten years). Concomitant medication included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). The patient experienced facial droop (left eye and mouth) on 23Feb2021 14:30, tired and sore arm on an unspecified date. The clinical course was as following: She said her appointment for the vaccine was at 08:00AM, and around 02:30PM she was in a video meeting and her left side of her face started to droop and her coworker messaged her to ask if she was ok since she looked pretty funny with the eye and mouth droop. She said that this droop lasted about 4 hours and by 06:30PM it was mostly resolved, if she was not looking at it or trying to raise her eyebrows. She said that the only other side effects were she was tired and had a sore arm. She said doctor asked her to got to the emergency room (ER) to rule out a stroke or transient ischemic attack (TIA) so they did a couple of Computerised tomogram (CT) scans, one with contrast and one without, and a MRI and they did full blood lab work up, and did an Electrocardiogram (EKG) to rule out central nervous system events. She says that they didn't think it was a TIA, they felt it was a peripheral nervous event related to an autoimmune response and all the tests said that they did not thought she had TIA event. She said doctor said it was likely an auto immune response to receiving vaccine, since there were no intervening events between getting the vaccine and the droop, she has not been sick or had any dental events recently. the main reason she was calling was to see if she should get the second dose, since she wanted to get it but has heard the side effects can be stronger for the second dose. She says she would like to know can she or should she take it. The patient was tested was for a stroke but that test came back negative. The patient would like to know if it is contraindicated for her to receive the second dose after having this reaction. The outcome of the event Facial droop was recovering, and the outcome of the event tired and sore arm was unknown.
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| 43 | 2021-03-14 | pain |
Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on...
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Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.
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| 43 | 2021-03-14 | dizziness |
sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other heal...
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sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 01Feb2021 13:45 at single dose for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 07:30, patient had sweating, palpitations, severe dizziness. The patient not received treatment for the event. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19.The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-03-15 | pain |
stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This i...
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stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL-9265), intramuscular in left arm on 04Feb2021 at 04:30 PM at single dose for COVID-19 immunization in pharmacy or drug store. Medical history included penicillin allergy. Concomitant medications included bupropion, buspirone and several different vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL-1283) in left arm on 14Jan2021 at the age of 42 years for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced stuffy nose, body aches, sore throat, swollen glands in the throat, general not feeling well on 05Feb2021 at 05:00 AM. No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-03-22 | pain, balance disorder |
Received Pfizer 2nd dose vaccine on 01/20/2021 at 7:00 AM in the patient's right arm - around 5:00 P...
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Received Pfizer 2nd dose vaccine on 01/20/2021 at 7:00 AM in the patient's right arm - around 5:00 PM the same day, the patient's knees started feeling wobbly, worse on left than the right. Knees continued to swell with limited motion, discomfort on bending, no point tenderness, and a negative meniscal exam. Swelling was worse on the left. X-ray normal. Worsening symptoms continued that limited standing and walking. Labs done on 2/2/2021 came back positive for Lyme disease and reactive arthritis. Swelling initially improved when patient was put on doxycycline, but worsened significantly after physical use. MRI showed large effusion in the left knee consistent with Lyme and a small focal lateral posterior horn meniscal tear not consistent with effusion. Effusion was drained March 1st and was PCR positive for spirochetes. WBC in effusion was 3400. Patient switched to amoxicillin and knee showed improvement by March 12th, 2021.
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| 44 | 2020-12-31 | numbness, pain, pain in extremity |
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ...
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After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
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| 44 | 2020-12-31 | dizziness |
Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving v...
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Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.
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| 44 | 2021-01-02 | numbness | numb pockets on face, a little swelling of tongue and a little tired/flushed |
| 44 | 2021-01-03 | pain |
12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the a...
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12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
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| 44 | 2021-01-03 | pain |
12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cou...
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12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)
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| 44 | 2021-01-03 | migraine | INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE |
| 44 | 2021-01-03 | numbness | Left cheek/ jaw numbness starting 10 min after injection |
| 44 | 2021-01-03 | tingling, feeling hot | felt hot, prickly, right arm red. Later felt chest tightness |
| 44 | 2021-01-03 | pain in extremity, pain |
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ...
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first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
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| 44 | 2021-01-04 | tingling, numbness, dizziness |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | tingling |
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she...
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Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
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| 44 | 2021-01-04 | pain, pain | FEVER, CHILLS, BODY ACHES, MALAISE |
| 44 | 2021-01-04 | lethargy, pain | Headache, lethargy, body aches for 24 hours |
| 44 | 2021-01-04 | dizziness |
fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left ...
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fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left elbow (tender to touch); This is a spontaneous report from a contactable other health professional (HCP, reported for herself). A 44-year-old female patient (not pregnant at the time of vaccination) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1830), intramuscular on 22Dec2020 12:45 at single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were none. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 22Dec2020 16:45 (04:45 PM), the patient experienced swollen left elbow (tender to touch), dizziness/headaches, high temperature, fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
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| 44 | 2021-01-04 | pain |
stiffness; Spreading from my shoulder up my neck to the base of my skull/worsening pain; Limited ROM...
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stiffness; Spreading from my shoulder up my neck to the base of my skull/worsening pain; Limited ROM; Horrific pain upon turning my neck towards the left; Woke up the following morning with a kink in my left neck; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ECT1685), via an unspecified route of administration in the left arm on 23Dec2020 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included anxiety, depression, hypothyroidism, lumbar fusion, and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), colecalciferol (VIT D3), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 09:00, the patient woke up the following morning with a kink in her left neck, which was similar to sleeping awkwardly. She applied some heat and took some ibuprofen (ADVIL). It persisted on 25Dec2020 and she did the same treatment. On 26Dec2020, the pain was exponentially worse and spreading from her shoulder up her neck to the base of her skull. She had limited range of motion. She had horrific pain upon turning her neck towards the left. She went to the emergency room on 27Dec2020 and 28Dec2020 due to the worsening pain, stiffness, and loss of function. The patient was treated with ibuprofen and unspecified muscle relaxers. The patient had not been tested for COVID-19 post vaccination. The clinical outcomes of the kink in her neck, neck pain, limited range of motion, worsening pain, and stiffness, were not recovered. The events were all reported as non-serious.
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| 44 | 2021-01-05 | pain in extremity, feeling hot |
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w...
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15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
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| 44 | 2021-01-05 | pain | Cold chills,body aches and major headache that lasted about 12 hrs |
| 44 | 2021-01-05 | dizziness |
Felt faint. Did not faint; however, assisted to floor to prevent falling/passing out. Resolved in ...
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Felt faint. Did not faint; however, assisted to floor to prevent falling/passing out. Resolved in 30 seconds Laid down and given water. Symptoms resolved. Vitals WNL. History of vasovagal reactions. Monitored for 15 minutes and released to home.
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| 44 | 2021-01-05 | tingling |
Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to ca...
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Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.
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| 44 | 2021-01-05 | feeling hot, pain in extremity |
Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40...
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Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40 minutes. Laid on a stretcher and systems resolved. Released to home.
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| 44 | 2021-01-05 | tingling, numbness |
I got the vaccine and three hours later I had both legs below the knee go numb and start tingling ....
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I got the vaccine and three hours later I had both legs below the knee go numb and start tingling . They are still tingling today but the numbness went away the day after I had the vaccine.
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| 44 | 2021-01-05 | migraine | Persistent migrane pain with nausea |
| 44 | 2021-01-05 | feeling of body temperature change, tingling, tremor |
Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE le...
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Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.? EE reports she pulled over and called her husband. At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.? EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am. Home remedies? - EE was in Starbucks parking lot at time of call and was going to be getting lunch after call. Recommendation? EE educated to eat and drink something, EE verbalized back understanding. EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-05 | pain, pain in extremity |
arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous ...
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arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization. Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events. Information about lot/batch number has been requested.
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| 44 | 2021-01-05 | pain |
developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfo...
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developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-05 | vertigo, pain in extremity |
immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing ...
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immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing headaches, fatigue, dizziness and nausea on and off every day
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| 44 | 2021-01-06 | tremor, dizziness | Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness. |
| 44 | 2021-01-06 | pain | FEVER,BODY ACHES, AND HEADACHE |
| 44 | 2021-01-06 | numbness, pain |
Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 tempera...
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Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 temperature, severe chills and joint pain (making it difficult to walk), body aches and extreme fatigue. Headache continued but facial numbness subsided. Symptoms less severe at 48hrs, low grade temp and body aches persisted, joint pain resolved. All symptoms resolved at 72 hrs.
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| 44 | 2021-01-06 | weakness, pain in extremity | Generalized Weakness, arm sore, sore throat, runny nose |
| 44 | 2021-01-06 | pain, nerve pain, tingling |
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur...
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Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
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| 44 | 2021-01-06 | migraine | Severe joint pain, migraine headache |
| 44 | 2021-01-06 | pain | fever 101.0, chills, aches |
| 44 | 2021-01-06 | dizziness, tingling |
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL...
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tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
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| 44 | 2021-01-07 | pain |
Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu bu...
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Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6) I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.
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| 44 | 2021-01-07 | tremor |
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha...
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Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
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| 44 | 2021-01-07 | pain |
Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous repo...
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Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 04Jan2021 14:00 at single dose Covid-19 immunisation. The patient was not pregnant. Medical history included hypothyroidism, tachycardia, fibromyalgia, and Covid prior vaccination. No known allergies. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included unspecified medications with 2 weeks of vaccination. The patient experienced Fever 100.2, Headache, Body aches, Joint pain, Chills, Diarrhea, Fatigue on 05Jan2020 02:00. The outcome of events was not recovered. This case was reported as non-serious. No emergency room/physician office visit. No treatment received for the events. Information on the lot/batch number has been requested.
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| 44 | 2021-01-07 | pain |
Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and he...
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Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.
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| 44 | 2021-01-07 | pain in extremity | I had fever and arm was sore. I felt fatigue and very tired. |
| 44 | 2021-01-07 | vertigo, pain in extremity |
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning...
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I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
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| 44 | 2021-01-07 | pain |
Increased left hand pain. More pain than typical arthritis pain; This is a spontaneous report from a...
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Increased left hand pain. More pain than typical arthritis pain; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at the left arm on 30Dec2020 17:00 at a single dose for COVID-19 immunization at a hospital. Medical history included ventricular septal defect (VSD), psoriasis, inflammatory arthritis, and migraines. Concomitant medications included fish oil, magnesium, paracetamol (TYLENOL ARTHRITIS). The patient previously took naproxen and experienced allergies. The patient experienced increased left hand pain that was more pain than typical arthritis pain on 31Dec2020, 12:00. The patient did not received any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient has not recovered from the events.
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| 44 | 2021-01-07 | migraine |
Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatr...
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Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatriptan having no effect
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| 44 | 2021-01-07 | numbness | Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative: |
| 44 | 2021-01-07 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at inject...
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Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
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| 44 | 2021-01-07 | pain | Reported chills,body aches, fever 100.3 |
| 44 | 2021-01-07 | pain in extremity | Sore arm, Joint pain, Fever, Fatigue, Back pain(muscles in back), Headache x 2 days so far |
| 44 | 2021-01-07 | tremor |
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; m...
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Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
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| 44 | 2021-01-07 | numbness |
Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first fing...
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Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first finger. Some swelling to the hand as well
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| 44 | 2021-01-07 | numbness | facial numbeness x 1h; bilateral Narrative: self limited bilateral facial numbness |
| 44 | 2021-01-07 | pain, weakness | moderate myalgias, fatigue, back pain, extremity pain and weakness |
| 44 | 2021-01-07 | tingling |
shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in t...
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shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in the forearm. loss of full range of mobility in the shoulder. this has been ongoing x 1 week.
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| 44 | 2021-01-07 | pain in extremity |
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv...
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slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
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| 44 | 2021-01-08 | pain |
Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pai...
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Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pain, severe headache. Second day I still have severe headache and nauseousness.
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| 44 | 2021-01-08 | dizziness | Dizziness Narrative: transient lightheadedness 60 seconds or less |
| 44 | 2021-01-08 | dizziness | Dizziness, Headache & NauseaVomiting Narrative: Need to stay home due to N/V, missed work day. |
| 44 | 2021-01-08 | pain | Fever 101.2 Chills Body aches Headache Losses of appetite |
| 44 | 2021-01-08 | pain in extremity, dizziness, pain |
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days...
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Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
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| 44 | 2021-01-08 | pain |
On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a...
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On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.
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| 44 | 2021-01-08 | tremor |
Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medic...
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Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.
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| 44 | 2021-01-08 | tremor |
Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three...
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Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.
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| 44 | 2021-01-09 | pain in extremity, numbness, tingling |
As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is s...
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As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is still there and I have chronic pain in my elbow running down my arm into my ring and pinkie finger.
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| 44 | 2021-01-09 | inability to speak, tremor |
I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwis...
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I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE. Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative. ---The Event: Monday morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx (could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding difficulties. After 30 min, totally back to normal.
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| 44 | 2021-01-09 | pain |
I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face ...
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I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.
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| 44 | 2021-01-09 | pain |
Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor l...
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Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor lumpy. Area aches and appears to be growing in size
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| 44 | 2021-01-09 | feeling cold, pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body ache...
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Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body aches, fatigue. Taking Tylenol and Aleve around the clock. Still ongoing.
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| 44 | 2021-01-10 | tenderness |
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar...
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1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
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| 44 | 2021-01-10 | pain in extremity, pain | Achy, chills, arm pain |
| 44 | 2021-01-10 | pain |
Chills, severe body aches - Tylenol taken at 7:40 PM which resolved most of the symptoms. No fever. ...
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Chills, severe body aches - Tylenol taken at 7:40 PM which resolved most of the symptoms. No fever. Body aches the next day but manageable without medication. All symptoms resolved after 48 hours.
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| 44 | 2021-01-10 | dizziness |
Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of...
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Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours
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| 44 | 2021-01-10 | pain | Fever 100.4/body aches/headache 24 hours-ibuprofen x 2 doses |
| 44 | 2021-01-10 | pain in extremity, feeling hot |
Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on r...
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Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.
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| 44 | 2021-01-10 | pain, dizziness | Light headedness, Foggy head, body ache, swelling in the axilla for 3 days after injection |
| 44 | 2021-01-10 | tingling |
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin...
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Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
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| 44 | 2021-01-10 | pain, tingling |
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr...
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Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
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| 44 | 2021-01-10 | pain | Strong headache, strong body aches, shortness of breath (fatigue) |
| 44 | 2021-01-10 | pain | Strong headache, strong body aches, shortness of breath (fatigue), tearful eyes |
| 44 | 2021-01-10 | dizziness, tremor | chills, shakes, nausea, vomiting, lightheaded |
| 44 | 2021-01-10 | pain |
difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fati...
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difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 44 | 2021-01-10 | pain | fever body aches head ache chills |
| 44 | 2021-01-11 | weakness, pain in extremity, pain |
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a...
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1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
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| 44 | 2021-01-11 | pain |
100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body ac...
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100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body aches; Extreme arm pain where the injection was given/Minor aches following the injection; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 04Jan2021 18:15 at SINGLE DOSE for COVID-19 immunization. Medical history included high cholesterol. The patient's concomitant medications were not reported. It was reported that the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 04Jan2021 18:30, the patient immediately had extreme arm pain where the injection was given and a headache. The next day (05Jan2021), the patient's arm pain was so bad on which she could hardly list her arm from the pain (minor aches following the injection). The patient also had extreme Body aches that night. Twenty-four hours after extreme body aches (06Jan2021), the patient had 100.4 low grade fever and chills for 2 to 3 hours. The patient did not receive any treatment for the events. The patient recovered from the events of low grade fever and chills on 06Jan2021 while the remaining events were in Jan2021 Information on the lot/batch number has been requested.
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| 44 | 2021-01-11 | pain |
11hours 30min after vaccine administration, Pt. starts to experience fever 103.1, Chills, body aches...
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11hours 30min after vaccine administration, Pt. starts to experience fever 103.1, Chills, body aches, fatigue. 28 hrs. from vaccination Pt still experiencing fever 102.3 with the use of fever reducing medications. body aches, fatigue
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| 44 | 2021-01-11 | feeling hot |
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and...
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24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
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| 44 | 2021-01-11 | feeling hot |
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rat...
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About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.
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| 44 | 2021-01-11 | pain, dizziness, weakness |
Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset st...
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Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset stomach
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| 44 | 2021-01-11 | pain |
Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer, the patient. A ...
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Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jan2021 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included already tested positive for COVID. There were no concomitant medications. On 04Jan2021 the patient experienced chills, fever, and body ache. Therapeutic measures taken as a result of chills, fever, and body ache included Tylenol 500 mg. The clinical outcome of the events chills, fever, and body ache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 44 | 2021-01-11 | lethargy | Fever 100-101degrees x 24hrs, Chills. Sweats, lethargy, headache |
| 44 | 2021-01-11 | dizziness, pain | Fever 101 degrees Severe Bodyaches Dizziness Symptoms lasted 24 hrs |
| 44 | 2021-01-11 | numbness, dizziness, tingling |
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i...
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I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
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| 44 | 2021-01-11 | migraine |
I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much ...
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I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much worse than my usual migraines. It was gone by the morning of 1/2/21. I was advised to report this.
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| 44 | 2021-01-11 | dizziness |
Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessmen...
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Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessment
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| 44 | 2021-01-11 | pain in extremity, weakness |
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f...
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Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
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| 44 | 2021-01-11 | feeling hot |
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ...
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On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
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| 44 | 2021-01-11 | tingling |
Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured fo...
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Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured for 3 minutes.
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| 44 | 2021-01-11 | weakness, dizziness, pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.
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| 44 | 2021-01-11 | pain |
Really bad chills; Body aches; Mild low grade temperature/fever; Sweating; Slight headache; Joints a...
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Really bad chills; Body aches; Mild low grade temperature/fever; Sweating; Slight headache; Joints are popping and cracking; Joint pain/joints hurt; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the upper left arm on 05Jan2021 (07:00) at a single dose for COVID-19 immunization at the hospital (not in a military facility). The patient had no relevant medical history and concomitant medications. On 05Jan2021 (14:00), the patient had really bad chills. On 05Jan2021, the patient had body aches; and had mild low grade temperature/fever. In Jan2021, the patient's joints were popping and cracking; had joint pain/joints were hurting; had slight headache; and was sweating. The patient was treated with ibuprofen for the events, 'chills' and 'mild low grade temperature/fever'. The outcome of the events was recovering for 'really bad chills' and 'body aches'; was not recovered for 'joint pain/joints were hurting' and 'slight headache'; was recovered on 06Jan2021 for 'mild low grade temperature/fever'; and was unknown for all the other events.
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| 44 | 2021-01-11 | involuntary muscle movements |
Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involu...
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Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involuntary muscle movements and lasted for 3 days
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| 44 | 2021-01-11 | pain in extremity, pain |
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow...
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Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
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| 44 | 2021-01-11 | pain | Uncontrollable chills, achiness, headache, nightmares |
| 44 | 2021-01-11 | pain, pain in extremity | body aches nausea, very sore arm 1 day after i2nd injection |
| 44 | 2021-01-11 | feeling hot | pt felt heart racing, warm ears and face. Pt monitored and given water. Symptoms resolved at 1721. |
| 44 | 2021-01-11 | involuntary muscle movements |
received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic rea...
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received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic reaction: involuntary muscle movements and lasted for 3 days,
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| 44 | 2021-01-11 | pain in extremity |
slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positi...
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slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positive COVID-19 test after first dose of vaccine; Fever; cold like symptoms; stuffy head; horrible headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program, Pfizer First Connect. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Dec2020 as a single dose (reported as 0.3 mL) (at the age of 44-years-old) for COVID-19 immunization. Medical history included ongoing hypothyroidism, one thyroid gland removed due to a nodule on an unspecified date (years ago), ongoing acid reflux, ongoing hypercholesteremia, ongoing fluid retention, and ongoing history of headaches. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism and for one thyroid gland removed due to a nodule from an unspecified date and ongoing, dexlansoprazole (DEXILANT) taken for acid reflux from an unspecified date and ongoing, atorvastatin (LIPITOR) taken for hypercholesterolemia from an unspecified date to an unspecified date, and hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for fluid retention from an unspecified date and ongoing. Additional concomitant medications included unspecified vitamins. The patient had a positive COVID-19 test after first dose of vaccine on 01Jan2021; cold like symptoms, stuffy head, horrible headache, cough, and fever on 31Dec2020; slight chest congestion on 02Jan2021; and slight sore arm on an unspecified date. The events, stuffy head and horrible headache, were reported as medically significant. The events, cough, fever, and slight chest congestion, were reported as non-serious. The clinical course was reported as follows: It was reported that the patient was vaccinated on 16Dec2020, became symptomatic on 31Dec2020, and tested positive for COVID-19 on 01Jan2021. The patient stated that she became symptomatic one day prior to testing positive for COVID-19, on 31Dec2020. She initially had cold-like symptoms with a stuffy head, cough and a horrible headache; the worst headache she had ever had. These symptoms occurred earlier in the day on the 31Dec2020. Then later that night about 10:00 PM, she had a fever with a body temperature of 102 degrees Fahrenheit. Her body temperature had been normal at 98 degrees all day that day until that night. She also had slight chest congestion and then was fever free for over 48 hours. The patient stated that she had a history of headaches and can tolerate a headache. The headache started 31Dec2020 and was significant. It was reported that after the vaccine, she had no other symptoms other than a slight sore arm, which lasted a day; maybe 24 hours after she received the vaccine. The patient stated that she does not think any of the other symptoms, other than the sore arm, have anything to do with the vaccine. The clinical outcome of positive COVID-19 test after first dose of vaccine and slight sore arm was unknown; cold like symptoms, horrible headache, and cough was recovering; fever was recovered on 02Jan2021; and stuffy head and slight chest congestion was not recovered. The reporter assessed the causality assessment between the events, positive COVID-19 test after first dose of vaccine, cold symptoms, stuffy head, cough, horrible headache, fever, and slight chest congestion, as unrelated. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-12 | feeling hot |
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was swea...
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10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.
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| 44 | 2021-01-12 | pain |
18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Ty...
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18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Tylenol or Advil, injection site pain. The symptoms were so severe that I was unable to go to work this morning. I have a headache, fatigue, feel foggy, and injection site pain still.
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| 44 | 2021-01-12 | migraine, dizziness |
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't...
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About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
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| 44 | 2021-01-12 | pain | Fever, body aches, headache. Resolved. |
| 44 | 2021-01-12 | pain, pain in extremity |
Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symp...
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Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symptoms. Still have left arm soreness on day 2 after injection . Body aches are better on the day 2 but not resolved yet, so his fatigue.
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| 44 | 2021-01-12 | numbness, tingling |
The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and...
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The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and left hand. I have never had this happen before. IT lasted for about 15 minutes that night. The day after that(1/9/21), it happened again in the evening and lasted about 10-15 minutes. The morning after that(1/10/21), I had the pins and needles/tingling and a bit of numbness in my left hand that lasted for a few hours. That evening(1/10/21), I had the sensations again in my left hand, as well as noticing a prickling/itching sensation on both of my shoulders. That lasted for about 30 minutes. That was the last time I experienced it and have not experienced it again in the last 2 days.
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| 44 | 2021-01-12 | dizziness |
Waves of nausea starting approximately 12.5 hours after vaccine dose received. General malaise and ...
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Waves of nausea starting approximately 12.5 hours after vaccine dose received. General malaise and feeling "faint" though blood pressure, temperature, heart rate, respiration and pulse oximetry WNL.
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| 44 | 2021-01-12 | numbness, inability to speak |
numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word findi...
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numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word finding issues that progressively worsened, LLE weakness. ct brain neg. MRI/MRA head and neck neg. labs neg. MRI of c spine t spine l spine s spine neg. emg and eeg neg. discharged from hospital. symptoms fluctuating. slowly improving.
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| 44 | 2021-01-12 | pain | temp 101 body aches chills massive HA congestion |
| 44 | 2021-01-13 | weakness |
12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24...
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12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24 HOURS AFTER THE VACCINATION AND THEN JUST TIREDNESS AND SLIGHT MYALGIAS FOR FURTHER 12 HOURS.
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| 44 | 2021-01-13 | pain |
12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING ...
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12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING - ACUTE ONSET OFSYMPTOMS HIGH FEVERS >101 - 103 F, SEVERE CONSTANT HEADACHES (PAIN SCALE AT 10), BODY ACHES, NAUSEA, FATIGUE, DIMISHED TASTE AND SMELL AND DIARRHEA SYMPTOMS CONTINUED TILL 1/7/2021 - SLOWLY IMPROVING
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| 44 | 2021-01-13 | feeling hot, pain in extremity, dizziness |
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita...
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5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
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| 44 | 2021-01-13 | pain |
Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling;...
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Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
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| 44 | 2021-01-13 | pain in extremity |
Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular ...
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Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular lymph node (left side- mildly tender), left sided neck pain, and left forearm tenderness that began almost 72 hours post vaccine. No fever. No other symptoms
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| 44 | 2021-01-13 | difficulty speaking |
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme...
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Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
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| 44 | 2021-01-13 | dizziness |
Patient reported feeling dizzy and lightheaded. Vitals listed below: 1214 - 122/68; 97%; 74; 16 1...
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Patient reported feeling dizzy and lightheaded. Vitals listed below: 1214 - 122/68; 97%; 74; 16 1219 - 110/66; 96%; 74; 18 1225 - 115/63; 96%; 75; 18 Patient was given water/juice and was discharged home in stable condition
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| 44 | 2021-01-13 | pain |
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),...
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Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
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| 44 | 2021-01-13 | dizziness, weakness |
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J...
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THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
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| 44 | 2021-01-13 | dizziness |
With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis...
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With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis. Patient was given water/juice and was discharged in stable condition home.
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| 44 | 2021-01-13 | pain | chills, body aches, fatigue |
| 44 | 2021-01-13 | pain |
constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes towa...
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constant pain in right underarm, swollen gland, sharp shooting pain in right underarm that goes toward right breast and up to the right side on neck. pretty painful.
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| 44 | 2021-01-14 | pain |
01/11/2021: Same day at 8 pm started to have body ache, headache, a little fever 100.1 and very tire...
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01/11/2021: Same day at 8 pm started to have body ache, headache, a little fever 100.1 and very tired. Took Tylenol. Got up next day at 12:30 a lot better. Today ok but not 100%.
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| 44 | 2021-01-14 | pain, weakness |
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives...
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0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
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| 44 | 2021-01-14 | vertigo, pain, dizziness |
1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg ...
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1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg was taken around the clock every 6 hours. It helps with the fever and also for the headache. 1/9/2021 woke up at 4:00 am with vertigo plus the above side effects. In addition to the Tylenol, I had taken dramamine in the morning and had been taking Meclizine 25-50 mg for the dizziness/vertigo. I also had done epley maneuver to help get rid of the vertigo since I am more dizzy turning on my right side and thinks that it is positional vertigo. 1/13/2021 still dizzy and taking Meclizine because it helps for the dizziness. I don't have anymore fever, the pain at the injection site is now mild, still moderate pain for the headache, some body aches but not as much as before. I had gone to the urgent care at this point to be seen since the vertigo is still there since Saturday 1/9 and it is now Wednesday 1/13. The doctor at the urgent care told me to continue taking Meclizine, hydrate and rest for a total of one week since the onset of the vertigo.
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| 44 | 2021-01-14 | dizziness, lethargy, weakness, tingling, facial paralysis, numbness |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | pain |
Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolv...
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Rash/hives, itching, fever, body aches Treating with Motion and Benadryl Fever and body aches resolved after 24 hrs Rash/hives and itching continue
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| 44 | 2021-01-14 | pain |
Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the...
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Received injection in left deltoid around 3 pm. At about 9:00 am my left axillary lymph node was the size of a quarter. It was very sore and painful to touch and movement. Pain scale 7/10. I treated it with warm compress infused with lavender oil, Ibuprofen 400 mg orally, self-massage, and rest. Symptoms lasted 24 hours. After 24 hours the lymph node was still swollen with dissipated soreness and pain. Pain scale 0-1/10.
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| 44 | 2021-01-14 | pain in extremity |
Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnan...
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Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Eh9899), via an unspecified route of administration in the left arm on19Dec2020 10:30 at a single dose for covid-19 immunization. The patient has no relevant medical history. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 19 December 2020, the patient experienced right arm pain. No treatment was given for the event. The outcome of the event was recovered. The vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Information on Lot/Batch has been requested.
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| 44 | 2021-01-14 | pain |
Severe side effect post 2nd covid vaccine. Started about 9-10 hours post vaccine. Fever (101.9+ F) ...
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Severe side effect post 2nd covid vaccine. Started about 9-10 hours post vaccine. Fever (101.9+ F) Rigor Severe body aches Severe headache Nausea
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| 44 | 2021-01-14 | pain | So far 12 hours of pain, body aches, chills and fever. Taking Tylenol and Benadryl |
| 44 | 2021-01-14 | pain in extremity |
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm...
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feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
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| 44 | 2021-01-15 | weakness |
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea...
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2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
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| 44 | 2021-01-15 | dizziness |
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed heada...
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About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
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| 44 | 2021-01-15 | pain | Fever 100 at 24hrs after shot Chills 6hrs Aches 24 hrs Joint pain 24 hrs Brain fog 1-2 days |
| 44 | 2021-01-15 | pain in extremity | Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021 |
| 44 | 2021-01-15 | tingling, numbness |
Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe i...
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Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11
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| 44 | 2021-01-15 | pain |
tired and headache started at 2:30pm. I slept all afternoon/evening. I had a fever of 102.3. I had b...
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tired and headache started at 2:30pm. I slept all afternoon/evening. I had a fever of 102.3. I had body aches. I'm still tired and achy.
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| 44 | 2021-01-16 | lethargy | Extreme lethargy, nausea, ?foggy brain? |
| 44 | 2021-01-16 | pain in extremity, numbness |
Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both f...
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Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both feet once muscle pain went away in extremities.
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| 44 | 2021-01-18 | numbness, pain in extremity |
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev...
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Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-19 | pain |
01/13: same day had staff having chill, fever 99.4, fatigue, headache. Friday 01/15; bodyache, head...
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01/13: same day had staff having chill, fever 99.4, fatigue, headache. Friday 01/15; bodyache, headache, no fever. Sat resolved. Now back to work.
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| 44 | 2021-01-19 | pain |
ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CH...
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ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CHEST, UPPER BACK AND STOMACH STARTING 2ND DAY AFTER VACCINE. LASTED A LITTLE LESS THAN 24 HRS. TOOK TYLENOL AND MOTRIN
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| 44 | 2021-01-19 | lethargy |
Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pa...
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Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pain & swelling
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| 44 | 2021-01-19 | pain | Headache, bodyaches, chills, |
| 44 | 2021-01-19 | pain in extremity, pain | Headache, pain in left arm, fever, chills, body aches, nauseous, fatigue |
| 44 | 2021-01-19 | seizure | Systemic: Anaphylaxis, Systemic: Seizure-Severe |
| 44 | 2021-01-19 | migraine, pain | migraine, fever, sweat, body aches, vomiting |
| 44 | 2021-01-20 | lightheadedness |
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C...
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near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-21 | pain |
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes...
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48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
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| 44 | 2021-01-21 | pain |
AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTIO...
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AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTION SITE
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| 44 | 2021-01-21 | dizziness, weakness |
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines...
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COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
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| 44 | 2021-01-21 | pain in extremity, dizziness |
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my...
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I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
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| 44 | 2021-01-21 | dizziness, pain in extremity |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-21 | lethargy | Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic. |
| 44 | 2021-01-21 | tingling, numbness |
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c...
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Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
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| 44 | 2021-01-24 | tremor, pain in extremity |
1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue...
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1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue. 1am that night, awoke with chills, fever (102), generalized muscle aches. By midday Thursday, these symptoms began to dissipate slightly and she developed a h/a. Friday, fever, chills, h/a were gone & nausea and abdominal pain started. No vomiting or diarrhea occurred. By SAturday evening, nausea improved but upper legs became tremulous and weak. Weak, tremulous legs have continued and persist up until today (monday, 1/25).
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| 44 | 2021-01-24 | pain |
Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold w...
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Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold with chills/ Was shivering; Fever; Sweating all night; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 31Dec2020 10:02 at a SINGLE DOSE for covid-19 immunisation. Medical history included tuberculosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BCG vaccine. The patient received Pfizer COVID Vaccine on 31Dec2020. On 04Jan2021, the patient got a couple of symptoms and started with a mild headache, not sharp pain and she took Tylenol. After she showered when she came home from work, she got chills. She took a couple more Tylenol, but doesn't know when. When she went to bed, she sweated all night and still feel cold with chills and was sweating all night. She didn't really check temperature, but knew she had a fever. On 05Jan2021, she woke up and felt like someone had hit her from her head to toes and every joint was aching, terrible body aches and couldn't walk. She went to emergency room on 05Jan2021 and thought she may have been exposed a couple of days before. She was working with patients who had COVID. She had a rapid COVID test that was negative and came home and symptoms continued. Today was the first day she was feeling a little better. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of mild, headache, cold with chills, cold with chills/ was shivering, fever, sweating all night , couldn't walk, terrible body aches, every joint was aching. The outcome of the events was unknown. Information was requested on Lot/ Batch number.
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| 44 | 2021-01-24 | pain, weakness |
Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks p...
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Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks post administration, range of motion is still decreased and weakness in that arm. Patient referred to specialized medicine.
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| 44 | 2021-01-24 | pain |
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur...
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Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
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| 44 | 2021-01-24 | dizziness, pain |
Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck,...
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Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck, behind eyes, and top of head) throbbing pain. Hurt to move eyes. Photosensitivity (eyes must remain shut at all times) Nausea, fever (102.3), sweats, chills Severe body aches (most prominent in lower back, hips, and legs/knees) Tylenol/ibuprofen alternating (reduced pain down to 4/10) 1st applied ice to lower back and surrounded head. This allowed me to sleep for almost 4 hours. Then applied heat to lower back. Continued to drink normally and eat bland diet These symptoms lasted all day. Around 11:30pm on 1/25 symptoms resolved with the exception of a headache requiring ice packs again throughout the night and tylenol. 9:22am today, still mild headache and get dizzy or a vertigo feeling if I change position too quickly or rotate my head too quickly
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| 44 | 2021-01-24 | pain in extremity |
very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; ...
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very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; This is a spontaneous report from a contactable nurse, reporting for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the left arm on 17Dec2020 at single dose for COVID-19 vaccination. Vaccination was done in a hospital. Medical history included celiac disease from 2011 and ongoing (very well controlled, she eats gluten-free. This is an autoimmune disease, but she is not immunocompromised like they ask with the Pfizer COVID-19 Vaccine. She is typically very healthy) and irritable bowel syndrome from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that following the first dose, she just experienced arm pain and general fatigue, just the basics. Arm pain and general fatigue with first dose she described as she did not really have a negative effect from; just the basics what everyone was saying. She did not feel anything when the first dose was injected; she did not have any issues until about 3 hours later that day on 17Dec2020 when she had onset of arm pain and general fatigue where she just felt tired for a few days; nothing big; she was able to work after the first dose; she just took ibuprofen for the first 2 days and the arm pain went away. She also mentioned that before getting the second dose of the vaccine she had a very low grade fever; it was 99.5 degrees Fahrenheit but she felt fine. Her stomach she was kind of having a little issue with loose stools for a few days before the second dose of the vaccine. She had celiac disease and a history of irritable bowel syndrome; and her uncle died on 02Jan2021 so she blamed the symptoms going on stress due to that. She does not know if maybe she was getting a GI cold at that time, the symptoms were a little mild before getting the second dose of the vaccine, she never felt sick or anything like that. She told the doctor about these symptoms during her appointment on 06Jan2021. Seriousness criteria of very low grade fever and a little issue with loose stools unknown. The patient underwent lab tests and procedures which included body temperature: 99.5 degrees fahrenheit on an unspecified date and COVID-19 test: negative on 06Jan2021. The outcome of the events was unknown. The reporter assessed the events arm pain and general fatigue as related to BNT162B2.
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| 44 | 2021-01-25 | pain | 1hr after - Headache, nausea. 2nd day - body aches and chills |
| 44 | 2021-01-25 | dizziness, weakness, pain |
7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, he...
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7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, headaches, dizziness,
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| 44 | 2021-01-25 | dizziness |
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines...
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Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
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| 44 | 2021-01-25 | pain |
Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, hea...
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Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received (not pregnant) her first dose of bnt162b2 (BNT162B2 also reported as Covid 19brand Pfizer BioNTech, lot EJ1685), intramuscular in the left arm 22Dec2020 10:00 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included covid prior vaccination: Yes. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced chills, low grade fever, body aches, headache " brain fog" on 23Dec2020 01:00. No treatment was given. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-01-25 | dizziness, weakness |
I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; ...
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I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; feeling nausea; my legs were weak; my throat got tight; This is a spontaneous report from a contactable HCP. This 44-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm at single dose for COVID-19 immunization on 08Jan2021 05:30 PM. Relevant medical history included osteoporosis and menopause. Known allergies included: soy, dairy, all nuts, sunflower, cottonwood, lentils, chickpeas, Vit E, cephalexin, Amoxicillin, sulfa, Bactrim, lisinopril , estrogen, moxifloxacin, Pseudoephedrine, paroxetine, trimethoprim, doxycycline, azithromycin, cipro, clindamycin, colestipol. The patient was not pregnant. Relevant concomitant drug included Vit D, calcium, ibuprofen. Five minutes after receiving the vaccine, her throat got tight then she started to feel lightheaded and her legs were weak. She notified the staff there who offered her Benadryl but she declined. She began feeling nausea about an hour later and she felt lightheaded and weak for about 4 hours. She started running a mild fever the next day and she still had a fever on 12Jan2021. The patient did not receive other vaccine in four weeks. The outcome of events was recovering. No treatment was received. The patient was not COVID infected prior vaccination. The patient did not have COVID tested post vaccination.
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| 44 | 2021-01-26 | pain | Cold chills, fever, throwing up,diarrhea,extreme headache and body aches |
| 44 | 2021-01-26 | dizziness |
Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limi...
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Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limits. O2 saturation normal. Started about 15 minutes after vaccination and lasted another 15 minutes. No medications or other interventions needed. Will follow up with their physician.
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| 44 | 2021-01-26 | feeling hot |
Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar ...
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Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar reaction with first dose. Requested to rest on a stretcher. BP 140/71, HR 93. Nausea and arm heaviness reported at 1605. BP 150/81, 10015sats; HR 87. At 1610 Heat in thighs. BP 125/66, HR 82 100% sats on oxygen. 1628: No further symptoms. Released home.
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| 44 | 2021-01-26 | feeling hot |
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing...
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Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
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| 44 | 2021-01-26 | feeling cold, numbness |
feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body n...
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feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-26 | dizziness | headache, lightheadedness, fatigue, joint pain, diarrhea, normal vaccine site tenderness, chills |
| 44 | 2021-01-27 | feeling hot, pain in extremity |
I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This i...
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I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and diabetic. Concomitant medications included lisinopril for high blood pressure, metformin for diabetes, and amlodipine. Today (11Jan2021), the patient just got hot and her hands started hurting. She was just feeling kind of boozy. She really had a bad headache. The patient was thinking why the lady didn't ask her if she was taking any medication or anything, she just asked if the patient was allergic to anything. The patient was not allergic to anything but she was taking medications. The patient asked if she should go and take her medication for tonight or hold until her symptoms go away. No treatment was received for the adverse events. The patient just lied down and have been sleeping for two hours. Outcome of the events was unknown.
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| 44 | 2021-01-27 | inability to speak, numbness |
on the evening of 1/11/21 pt started to talk to her children and she "could not access the words." T...
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on the evening of 1/11/21 pt started to talk to her children and she "could not access the words." Then she tried to text and couldn't figure out the vocabulary. She went to the ER where she was transported to hospital, under stroke protocol. She also c/o right hand numbness at the er. She was admitted and test run. No evidence of a stroke.
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| 44 | 2021-01-28 | swollen extremities |
Had first vaccination on 1/6/21. After second injection, severe pain under her right arm with swell...
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Had first vaccination on 1/6/21. After second injection, severe pain under her right arm with swelling that has not subsided after 24 hours.
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| 44 | 2021-01-28 | dizziness | Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure |
| 44 | 2021-01-28 | tenderness, pain in extremity |
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hou...
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The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure. There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult and very painful to try and extend my arm out to the side, which continues to today 01/29/2021.. My entire arm is still tender and sore, tricep, bicep, and shoulder. It is difficult to sleep and work due to the pain.
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| 44 | 2021-02-08 | pain |
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle...
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Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
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| 44 | 2021-02-09 | pain in extremity |
I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for abou...
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I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for about 24-36 hours. I was very tired for about 7 days all I did was sleep.
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| 44 | 2021-02-15 | dizziness |
Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. ...
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Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. Started at home for there days from work. Tongue and throat are still sore.
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| 44 | 2021-02-21 | dizziness |
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ...
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1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
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| 44 | 2021-02-21 | pain, numbness |
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that...
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About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
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| 44 | 2021-02-21 | pain in extremity |
Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm...
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Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.
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| 44 | 2021-02-21 | facial paralysis, inability to speak |
I started feeling really tired (couldn't move type tired). I called off worked for few days. On the ...
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I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.
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| 44 | 2021-02-21 | pain, pain in extremity, dizziness, tenderness |
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed...
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Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
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| 44 | 2021-02-21 | weakness, migraine, pain |
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai...
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Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
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| 44 | 2021-02-21 | dizziness |
Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwi...
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Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.
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| 44 | 2021-02-22 | pain |
5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever...
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5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED
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| 44 | 2021-02-22 | dizziness, weakness |
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th...
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Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 44 | 2021-02-22 | pain in extremity, dizziness |
I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facilit...
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I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine. On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness. I already had the following week off work, so I napped when I could. I have been tired as well. I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.
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| 44 | 2021-02-24 | weakness | Chills, Muscular pain, Fever, Headache, Weakness. |
| 44 | 2021-02-25 | dizziness, pain |
I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to ...
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I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
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| 44 | 2021-02-25 | pain in extremity |
Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contac...
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Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 44 | 2021-03-02 | dizziness, feeling hot, tingling |
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP...
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Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
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| 44 | 2021-03-02 | weakness |
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation...
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Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
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| 44 | 2021-03-04 | balance disorder, numbness, dizziness, tingling |
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l...
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Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
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| 44 | 2021-03-09 | feeling hot, weakness |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-10 | lightheadedness, weakness, tremor |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-11 | dizziness |
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on...
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dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-14 | pain |
Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable ...
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Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL926lt) via an unspecified route of administration in the left arm on 07Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. The patient did not have allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received infliximab (REMICADE) infusions from an unknown date for ulcerative colitis; and received the first dose of BNT162B2 (lot number El3247) in the left arm on 17Jan2021 at 12:00 (at the age of 44-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within the 4 weeks prior to the COVID vaccine. On 08Feb2021 at 00:15 the patient experienced chills, fever, body aches, dull headache, and vomiting. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The events of chills, fever, body aches, dull headache, and vomiting were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
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| 44 | 2021-03-14 | pain |
Fever; severe body aches and pain; This is a spontaneous report from a contactable Other Health Prof...
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Fever; severe body aches and pain; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 44-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) via an unspecified route of administration from 29Jan2021 10:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included lurasidone hydrochloride (LATUDA), lisinopril and metoprolol. The patient experienced fever and severe body aches and pain on 30Jan2021 at 12:00 AM. No treatment was received for the adverse events. The outcome of the events was reported as recovered. The events were assessed non-serious. Information on the lot/batch number has been requested.
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| 44 | 2021-03-14 | pain |
I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested ...
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I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested diagnosed with pneumonia was prescribed two inhalers. On week three started running fever even after two antibiotics.Im recovering still exp shortness of breath at times.
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| 44 | 2021-03-14 | pain |
fatigue; headache; body aches; fever; This is a spontaneous report from a contactable consumer (pati...
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fatigue; headache; body aches; fever; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: unknown), via an unspecified route of administration on 10Feb2021 08:15 (at age of 44-year-old) at single dose in left arm for COVID-19 immunisation. Medical history includes diabetes mellitus. There was no known allergies. No other vaccine was received in four weeks. Concomitant medication included empagliflozin (JARDIANCE), metformin for diabetes, semaglutide (OZEMPIC), atorvastatin (LIPITOR), sertraline. The patient experienced fatigue, headache, body aches, and fever on 10Feb2021 14:00. No treatment was received for the events. There was no COVID prior vaccination or no COVID tested post vaccination. The events did not result in emergency room visit or physician office visit. The outcome of events was resolving. Information on the lot/batch number has been requested.
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| 44 | 2021-03-15 | pain |
lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel ...
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lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-03-17 | bell's palsy, feeling hot |
Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red ...
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Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red face and ears all day; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at single dose in right arm for covid-19 immunisation at the age of 44-year-old. Lot number was Ez9264. Medical history included asthma, interstitial cystitis, allergy to peanuts. The patient experienced anaphylactic reaction with GADAVIST. Concomitant medications were unknown. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 04:30 in right arm at the age of 44-year-old for Covid-19 immunisation (lot number was Gl3249). The patient was not pregnant. On 03Feb2021 at 07:15, the patient experienced extreme heat in face that lasted 2 minutes. Red face and ears all day but no more extreme heat. On 06Feb2021, Bell's palsy on right hand side of face occurred. The patient was not treated for the events. The patient did not recover from the events. Patient was not covid tested post vaccination; patient did not have covid prior vaccination.
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| 44 | 2021-03-17 | feeling hot, dizziness |
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to am...
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Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc. After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues. She then stated she was feeling much better again, her warm feelings were going away from ice in a glove that we had used from her initial dizzy, warm/hot feeling. Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so. Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
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| 44 | 2021-03-22 | dizziness |
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea...
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I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00. Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
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| 45 | 2020-12-31 | pain in extremity |
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d...
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12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
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| 45 | 2020-12-31 | numbness |
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a...
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Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
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| 45 | 2021-01-01 | feeling hot |
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt...
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Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
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| 45 | 2021-01-01 | tingling |
Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm ...
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Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm felt the same with slight improvement in my right arm. Later that day, I felt tingling in my left leg down to my toes. I have felt these symptoms every day since, but they have improved in severity, moving from one side to the other at times. This has not affected my activities of daily living, nor my work as a RN.
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| 45 | 2021-01-02 | feeling cold, weakness, dizziness, pain | Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell. |
| 45 | 2021-01-02 | vertigo, lightheadedness |
Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable...
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Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.
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| 45 | 2021-01-03 | pain in extremity | 24hr extreme malaise (charley horse left calf) left arm pain 24hr temporal headache 24hr |
| 45 | 2021-01-03 | weakness, tingling, pain in extremity, numbness |
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a...
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After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
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| 45 | 2021-01-03 | pain in extremity, pain |
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach...
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Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
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| 45 | 2021-01-03 | tingling | Tingling of face for a couple hours, starting 2 hours after vaccine, gone by the next day |
| 45 | 2021-01-03 | feeling hot, numbness | right arm numbness, sensation of throat constriction and heat in her body |
| 45 | 2021-01-04 | numbness, tingling |
Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle...
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Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle then went numb roughly 45-55 minutes after receiving.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received bnt162b2 (lot number: EL0140, Pfizer- BioNTech), intramuscularly at arm left, first dose on 23Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included environmental allergies, iron deficiency anemia, endometriosis, allergies to penicillin, and allergies to preservatives in flu vaccine from an unknown date. The patient is not Pregnant at the time of vaccination. Concomitant medication included ibuprofen, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), magnesium, all from an unspecified date, for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Age at vaccination is 45 Years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced face started to tingle then went numb roughly 45-55 minutes after receiving (reported as from 23Dec2020, 08:30 AM). Not sure if that is an actual reaction but it occurred. The event was reported as non-serious. Therapeutic measures were taken as a result of face started to tingle then went numb roughly 45-55 minutes after receiving, treatment included BENADRYL orally taken. The outcome of the event was recovered in Dec2020.
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| 45 | 2021-01-04 | feeling hot |
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ...
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Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
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| 45 | 2021-01-04 | tingling |
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin...
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Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
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| 45 | 2021-01-04 | tingling |
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ...
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Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
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| 45 | 2021-01-04 | tenderness, pain |
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou...
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Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
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| 45 | 2021-01-04 | dizziness, vertigo |
Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur...
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Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur sitting to standing; Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur sitting to standing; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 10:00 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history included psoriasis. Concomitant medications included adalimumab (HUMIRA) and famotidine (FAMOTIDINE). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 17:00, the patient experienced onset dizziness when turning to the left or going from laying to sitting / standing but does not occur sitting to standing. The patient did not receive any treatment for the events. Outcome of the events were not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-04 | dizziness |
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde...
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dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-01-04 | pain in extremity |
had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This...
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had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 24Dec2020 08:15AM at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included lyme disease from 2014. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines in last four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 25Dec2020 07:30AM, the patient had a severe pain in upper left hip. It felt like an IT band issue she had before but this time it didn't radiate to her knee like it usually does. She did not have exercise since the morning of the 22nd when she did an upper body weight-lifting session. She took ibuprofen that took the edge off, and she was able to finish her day as a nurse in the Covid ICU. The following morning, she felt fine and went to her other job. She was fine in the morning during her usual drills practicing getting out of the helicopter while on the ground. She sat in one of the seats for about 15 minutes while having a discussion when she started to feel the pain again. She got out of the helicopter and tried to walk around, but it hurt to lift her left leg up (while taking a step forward) in Dec2020. She has never experienced this before. She limped back to the hanger, took ibuprofen 600mg and rested/stretched for an hour. The pain was reduced to a minor and tolerable ache. The outcome of the events was recovering. The report was considered non-serious.
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| 45 | 2021-01-05 | inability to speak |
Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine...
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Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.
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| 45 | 2021-01-05 | dizziness |
Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No...
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Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No change in voice, no wheezing , able to drink and swallow water without difficulty. Vital signs and O2 saturation /oximetry were normal. After 30 min into observation, she c/o lightheartedness and both eyes were puffy. Vitals: BP 129/75, hr 91, O2 sat 99% at room air . Benadryl 50 mg IM given and client was taken to the Emergency room..
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| 45 | 2021-01-05 | dizziness |
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br...
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[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
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| 45 | 2021-01-05 | dizziness |
next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms star...
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next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
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| 45 | 2021-01-06 | dizziness |
12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartb...
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12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.
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| 45 | 2021-01-06 | facial paralysis, tingling |
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte...
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Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
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| 45 | 2021-01-06 | tremor |
At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my...
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At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.
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| 45 | 2021-01-06 | pain | DIffues hives over chest, abdomen, back, arm |
| 45 | 2021-01-06 | dizziness | Dizziness Little wave of dizziness 100/62 HR62 O2 99%, 100/67 HR 73 Narrative: |
| 45 | 2021-01-06 | pain | Fever and body aches, feels poorly. Stayed home from work |
| 45 | 2021-01-06 | restlessness |
Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- re...
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Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Sleep affected- awake 22 hours; Hyperactive anxiety reaction; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685 /expiration date: not provided), via an unspecified route of administration in the left arm, on 28Dec2020 at 07:45 AM (at the age of 45 years old) as a single dose for COVID-19 vaccination. Relevant medical history included penicillin allergy. The patient did not have any chronic diseases or illnesses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 10:00 AM, the patient experienced hyperactive anxiety reaction- restless, impulsive and hyperactive. The patient could not sit still or control fidgeting and her sleep was affected, as she was awake 22 hours. The patient did not receive treatment for the events. The outcome of the events hyperactive anxiety reaction- restless, impulsive and hyperactive and sleep was affected was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-01-06 | pain, tingling, vertigo |
I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. ...
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I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.
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| 45 | 2021-01-06 | nerve pain, pain in extremity |
Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but ...
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Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but now she is having nerve pain in her right thumb.
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| 45 | 2021-01-06 | dizziness |
When patient initially received the vaccination, she complained of mild dizziness. She went home aft...
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When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.
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| 45 | 2021-01-06 | tingling |
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti...
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Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
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| 45 | 2021-01-06 | weakness, dizziness | around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak; |
| 45 | 2021-01-07 | dizziness |
06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizz...
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06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.
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| 45 | 2021-01-07 | pain | Chills, fever 101.2 (oral), headache, nausea, vomiting, body aches. |
| 45 | 2021-01-07 | pain | Chills, fever, body aches, joint pain, painful lymph nodes in armpit, headache, nausea |
| 45 | 2021-01-07 | pain in extremity |
Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse ...
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Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports. A 45-year-old female patient received a single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on 29Dec2020 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, on 29Dec2020, the patient had arm soreness and it lasted a few hours. The patient took Tylenol and was fine. She also developed diarrhea and headache, and her symptoms hit her all of a sudden late afternoon on 04Jan2021. No treatment was received. She woke up in the morning of 05Jan2021 and it was all gone. She had a COVID test on 05Jan2021 and it was negative. The patient recovered from the arm soreness on 29Dec2020 and recovered from diarrhea and vomiting on 05Jan2021. The events were considered related to the vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 45 | 2021-01-07 | dizziness, restlessness |
Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, woo...
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Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, wooziness, mild nausea, mild abdominal pain. No asthma symptoms.
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| 45 | 2021-01-07 | pain | Fever 102.5 x 24 hours at this time. Chills, body aches, headache and fatigue. Some chest discomfort |
| 45 | 2021-01-07 | pain | Fever, Chills and generalized body aches . |
| 45 | 2021-01-07 | tremor | Fever, Headache, Shaking Chills, Discomfort in the body. I am taking Panadol every four hours. |
| 45 | 2021-01-07 | lethargy |
Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: V...
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Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and "tight" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.
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| 45 | 2021-01-07 | pain in extremity |
I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain o...
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I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days. On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction. They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21. The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles. I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.
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| 45 | 2021-01-07 | pain in extremity, pain |
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject...
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Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Rapid Response called @1721, patient monitored.
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| 45 | 2021-01-07 | dizziness |
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started...
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Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
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| 45 | 2021-01-07 | pain | chills in evening after vaccination, chills next day in AM then nausea and body aches, temp 102. |
| 45 | 2021-01-07 | dizziness |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness neg...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
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| 45 | 2021-01-07 | dizziness |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y n...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test
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| 45 | 2021-01-07 | pain | headache, chills, body aches and generalized unwell feeling |
| 45 | 2021-01-07 | tingling |
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, th...
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minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.
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| 45 | 2021-01-07 | pain in extremity |
sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old ...
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sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as COVID-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. Medical history included rheumatoid arthritis and allergic reactions (unspecified). Concomitant medications were not reported. After receiving the first dose of the vaccination the patient experienced a sore arm on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-01-07 | dizziness, pain |
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting...
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typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
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| 45 | 2021-01-08 | bell's palsy |
Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Pro...
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Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Provider with prednisone
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| 45 | 2021-01-08 | dizziness, lightheadedness |
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour...
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Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
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| 45 | 2021-01-08 | pain | Fever, body aches, headaches, tiredness |
| 45 | 2021-01-08 | numbness |
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm...
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I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
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| 45 | 2021-01-08 | pain in extremity |
Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headach...
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Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headache. Took Aleve, headache gone. Day 2 at 1am, woke up with pretty bad arm pain ("why does my arm hurt so bad? Have I lifted too much weight at the gym?") and headache Did nothing; went back to sleep. Day 3, took Aleve again in the evening; headache gone. Day 4, mild headache. Day 5 and on, feeling fine. On Jan 5, for 4 days straight, I fell asleep at 6 and 7 pm. Normally I go to bed at 9am ( I get up at 4am). Felt fine enough to work, just tired at night more than usual. My 2nd dose is scheduled Jan 15 at noon.
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| 45 | 2021-01-09 | pain |
Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I ha...
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Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I had a fever of 99.9 degrees F ( normally 97.2 for me). The next day I had a headache and felt fatigue. I had diarhea 3 more times. My spine ached a little when I went to bed about 11pm. No side effects by 1/10/21
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| 45 | 2021-01-09 | pain |
Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs....
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Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs. I then had extreme fatigue, nausea and headache for another 10hrs.
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| 45 | 2021-01-09 | dizziness |
on day of injection approx 13 mins after injection RN was called to her car. She reported throat tig...
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on day of injection approx 13 mins after injection RN was called to her car. She reported throat tightness, and dizziness 911 was called and pt was monitored until symptoms improved. Was not transported to ED. 2 days later developed a hive like rash and was seen at walk in clinic was treated with prednisone.
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| 45 | 2021-01-09 | pain in extremity | slight headache fatigue sore arm |
| 45 | 2021-01-10 | pain in extremity |
About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after an...
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About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after and still today intermittent vision(focus) issues and twitching of right eye with some slight right eye pain
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| 45 | 2021-01-10 | numbness, facial paralysis, bell's palsy |
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ...
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BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
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| 45 | 2021-01-10 | pain, weakness |
Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling su...
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Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling super tired with no energy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 45-year-old female patient who receive first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on Saturday (02Jan2021) at single dose (once by injection in the right arm) for covid-19 immunisation. Medical history included ongoing Hypothyroidism from 2008. Concomitant medications included levothyroxine at 75 ug ongoing from 2008 for Hypothyroidism. Medical Professional and told by her work that she could get it because contact with COVID patients. The consumer calls for information about if the side effects she is experiencing after the administration of the COVID-19 vaccine will last for more days. The consumer reported tiredness and other side effects to DSU. A Consumer calls for information about if it would be appropriate the second dose of the COVID-19 vaccine is not administered considering that she had adverse reactions. Consumer calls for information about if the second dose of the COVID-19 vaccine would cause her more side effects than the first one. Received the vaccine on Saturday, 02Jan2021. The day she got it she did not feel anything at all. She was completely fine. She did not even have pain at the injection site. The next day, on Sunday she started feeling super tired with no energy, had body aches, and cramping in legs from 03Jan2021. She has had these for the past 3 days now. She also had chills with no fever from 03Jan2021 to 05Jan2021. She took Tylenol for the first 2 days, but it did not help her at all. She is feeling a little better today, but not much. Her question is, how long will these side effects last? Tylenol: She says it did help a little bit. She think she would just sleep because she was uncomfortable. The Tylenol just did not make her symptoms go away completely. LOT/Batch: AA46487, EXP: Apr2022 UPC: The consumer says the number under the barcode is: 5187536. Feeling super tired and body aches: Has improved about 20%. She says these are all medically significant as she is not able to do what she was able to do before getting the vaccine. She is super tired with no energy and she is confined to her bed most of the time. The consumer confirms this is her first dose of the COVID Vaccine. She thinks she got the standard dose. Vaccine card does not have the expiration date or NDC written on it. Unknown causality. She said that she could be positive for COVID. She is unsure. The outcome of the event Chills with no fever was recovered. The outcome of the event Cramping in legs was not recovered. The outcome of the other events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-10 | pain |
First dose of vaccine was received on 12/22/2020. Became COVID test positive on 12/30/2020. Had bod...
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First dose of vaccine was received on 12/22/2020. Became COVID test positive on 12/30/2020. Had bodyaches, sore throat on 12/29/2020. Symptoms improved in 4 days.
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| 45 | 2021-01-10 | dizziness |
HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injecti...
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HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injection no treatment no improvement.
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| 45 | 2021-01-10 | bell's palsy, facial paralysis, slurring |
Patient reports having Bell's Palsy with photographic evidence that was noticed approximately 11 hou...
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Patient reports having Bell's Palsy with photographic evidence that was noticed approximately 11 hours (at 7:00pm) after vaccine administration. Patient reports having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days). Bell's Palsy resolved by 01:00am.
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| 45 | 2021-01-10 | feeling hot |
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv...
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Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
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| 45 | 2021-01-10 | numbness |
Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monda...
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Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monday 1/4/21- Started feeling some slight numbness on right side of face and front of tongue, headaches continued on and off throughout the day. Tuesday 1/5/21- Woke up to get ready for work and I noticed my right eyelid was a little swollen and right side of my mouth was numb and smile was slightly crooked. Arrived at work and my right eye was not blinking properly. I went to ER room to seek treatment and was prescribed Prednisone and Valacyclovir. Wednesday 1/6/21- Started with right ear pain that radiated down to right side of neck. This is the second time I've had Bells Palsy. First time was in 1997 when I was age 22.
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| 45 | 2021-01-10 | dizziness |
While sitting upright I became dizzy. I was assisted to my bed room and remained dizzy throught. W...
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While sitting upright I became dizzy. I was assisted to my bed room and remained dizzy throught. While laying down I was dizzy. I took some tylenol pm and went to sleep. When awakening, I was not dizzy. Occasionally on day two and three, I feel like its going to start again but it has not.
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| 45 | 2021-01-10 | pain, pain in extremity |
arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, t...
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arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, throbbing arm pain
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| 45 | 2021-01-10 | lightheadedness | vasovagal episode drop in pulse ox drop in heart rate |
| 45 | 2021-01-11 | pain in extremity, feeling hot |
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ...
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A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
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| 45 | 2021-01-11 | pain, dizziness |
Around 6 hours after getting the 2nd vaccine at my place of employment (I am a RN) I was very nausea...
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Around 6 hours after getting the 2nd vaccine at my place of employment (I am a RN) I was very nauseated and dizzy. Couldn?t even walk straight. Then at 0200am I woke up with a 102.8 fever, Heart rate of 159 and body aches along with the dizziness and nausea. It is currently 530pm and I still have all symptoms, heart rate is a little better, around 100. I?m controlling my temperature with Advil and tylenol.
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| 45 | 2021-01-11 | dizziness | Chest tightness, dizziness, chills. No reported treatment and symptoms resolved. |
| 45 | 2021-01-11 | dizziness |
Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for hersel...
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Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EK9231), via an unspecified route of administration in left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse. Patient was allergic to some chilis and animals. There were no concomitant medications. The patient experienced dizzy, flushed after injection on 03Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient been not been tested for COVID-19. Outcome of events was recovered in Jan2021.
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| 45 | 2021-01-11 | feeling hot |
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ...
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Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
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| 45 | 2021-01-11 | tingling |
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ...
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Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
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| 45 | 2021-01-11 | feeling hot, feeling cold |
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno...
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Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
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| 45 | 2021-01-11 | nerve pain, pain in extremity |
Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontan...
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Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730, expiry date: unknown), intramuscular on the right arm on 16Dec2020 11:00 to at a single dose for an COVID-19 immunization. Medical history included hypertension, obesity, lymphadenopathy, and migraines. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan, clonazepam (KLONOPIN), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX), and zinc. The patient experienced right arm soreness, kinda like nerve pain and can't lift her arm up or reach the back on 16Dec2020. Outcome of the events was not recovered. No treatment was received for the events. The patient underwent lab test which included COVID test (nasal swab) on 19Dec2020 and 26Dec2020: both negative. The reporter considered the events non-serious.
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| 45 | 2021-01-11 | dizziness | SOB, dizziness, nervous, headache Treatment: IV Prednisone, IV Benadryl |
| 45 | 2021-01-12 | tingling, pain |
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a...
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12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
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| 45 | 2021-01-12 | pain |
After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am . On 1/12/2021 at 5:36...
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After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am . On 1/12/2021 at 5:36 am I started to experiencing headaches, slight fever and whole body aches, and both of the back and front of my calf's muscle felt very heavy had a hard time getting out of bed and not able to walk well, I took Ibuprofen every 6 hours. The Ibuprofen helped with the headaches and fever. on 1/13/2021 I woke up feeling better, no fever just very tired and had 3 headaches during the day.
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| 45 | 2021-01-12 | pain |
After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am. on 1/12/2021 at 5:36 ...
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After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am. on 1/12/2021 at 5:36 am waking up I started experiencing slight fever, headaches, whole body aches and both of the back and front of my Calf's muscles felt very heavy. I took Ibuprofen every 6 hour .
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| 45 | 2021-01-12 | pain, feeling hot |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-12 | pain | Body aches, fatigue. Improving. |
| 45 | 2021-01-12 | feeling cold | Chills, joint pain, redness/swelling/itching at injection site |
| 45 | 2021-01-12 | pain | Fatigue, body aches. Improving. |
| 45 | 2021-01-12 | pain in extremity | Fever 100.9 for 5 days. Muscle aches, chills, headache. Arm pain entire left arm. |
| 45 | 2021-01-12 | pain, feeling hot | HOT, HARD RED AREA, BLISTERING, PAINFUL |
| 45 | 2021-01-12 | pain in extremity |
In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours a...
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In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours after the initial vaccine was given, I developed low-grade fevers. headaches, myalgia, chills, and severe fatigue. It?s now about 48 hours later and I still experience mild fevers occasionally.
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| 45 | 2021-01-12 | numbness |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
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| 45 | 2021-01-12 | numbness |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
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| 45 | 2021-01-12 | pain |
The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours a...
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The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.
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| 45 | 2021-01-12 | dizziness, pain in extremity |
The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Sat...
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The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Saturday two days after the second dose I had significant dizziness which might be considered vertigo. I am now six days past the second vaccine and continue to have dizziness.
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| 45 | 2021-01-12 | dizziness |
Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:2...
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Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.
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| 45 | 2021-01-12 | weakness, feeling hot, dizziness |
after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrin...
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after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility
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| 45 | 2021-01-12 | pain |
on 1/11/21, developed swollen lymph node on right clavicle area- pea sized tender to touch, sore wi...
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on 1/11/21, developed swollen lymph node on right clavicle area- pea sized tender to touch, sore with head movement to the left.
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| 45 | 2021-01-12 | dizziness | severe dizziness, fever, fatigue |
| 45 | 2021-01-13 | dizziness |
1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibupr...
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1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibuprofen at 1:00 am, reduced/eliminated headaches by Dec. 31, 2020 3:00 p.m. 2. Jan. 01, 2021- Woke up/laying down when the dizziness/room spinning began lasting about 10 seconds. Dizzy/spinning episodes continued from 01/01/2021-01/05/2021 (decreasing in episodes on 01/04/2021- 01/05/2021). The dizzy/spinning episodes would happen randomly when I first woke up, through out the day/night, about 6-7 times a day, and lasting about 10 seconds. A few times I felt like I would faint. Treated with rest, sleep, drinking water, and took off work for 1 week due to the danger of driving or going outside the home. 3. I would randomly wake up with hot sweats and nausea from 01/01/2021-04/01/2021, treated by drinking water, and resting. 4. I experienced the general feeling of being unwell, fatigue, and foggy mind that lasted about a week after the 1st COVID-19 vaccination. Treated with rest and was off work for 1 week.
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| 45 | 2021-01-13 | dizziness |
15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palp...
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15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palpitations, lightheadedness and feeling faint. Patient's symptoms resolved by 4:15pm. Patient was prescribed Benadryl 50mg PO and PEPCID 40mg PO. Patient discharged from EC home at 6pm.
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| 45 | 2021-01-13 | tingling, facial paralysis |
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra...
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Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
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| 45 | 2021-01-13 | feeling cold |
FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJEC...
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FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.
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| 45 | 2021-01-13 | pain | Fever, Body aches, Chills. |
| 45 | 2021-01-13 | dizziness |
Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it...
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Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it did help.
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| 45 | 2021-01-13 | dizziness |
On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nau...
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On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nausea, headache, dizziness, fever-100.7, muscle ache, swollen gland still
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| 45 | 2021-01-13 | dizziness |
Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous r...
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Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 04:30 PM at single dose (vaccine location: left arm) for COVID-19 immunisation. The patient previously experienced allergies with penicillin and levofloxacin (LEVOQUIN). Concomitant medications in two weeks included cetirizine hydrochloride (ZYRTEC), colecalciferol (VIATAMIN D) and hormone replacement pellets. Patient did not have other vaccine in four weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe dizziness 36 hours after vaccination, mouth breaking out in ulcers, extreme tiredness and headache on 01Jan2021. No treatment received for events. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
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| 45 | 2021-01-13 | pain | Slight body aches, diarrhea and mild headache |
| 45 | 2021-01-13 | pain |
body aches; Chills; low grade fever; This is a spontaneous report from a contactable consumer. A 45-...
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body aches; Chills; low grade fever; This is a spontaneous report from a contactable consumer. A 45-year-old female patient started to receive bnt162b2 (BNT162B2, lot number EK9231), intramuscular (left deltoid) from 06Jan2021 08:30 to 06Jan2021 08:30 at 0.3 mL, single for covid-19 vaccination. Medical history included ongoing asthma. The patient also received first dose of bnt162b2 on 16Dec2020. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and salbutamol sulfate (ALBUTEROL); both ongoing given for asthma. It was reported that the patient received the second Pfizer covid19 vaccine dose yesterday around 8:30am. She is calling to report that she experienced body aches, chills, and a low-grade fever which all started around 8pm yesterday (06Jan2021). For the treatment, she is taking Tylenol. The outcome of the events was unknown.
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| 45 | 2021-01-13 | dizziness |
patient reported lightheadedness and leg heaviness. BP 153/102, HR 110-120, O2 100%. Patient was tr...
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patient reported lightheadedness and leg heaviness. BP 153/102, HR 110-120, O2 100%. Patient was transferred to ER via stretcher.
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| 45 | 2021-01-13 | pain in extremity |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-14 | tingling, dizziness |
About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal an...
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About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm. Vital signs within normal limits. Improved
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| 45 | 2021-01-14 | numbness |
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then...
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After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
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| 45 | 2021-01-14 | feeling hot |
Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extrem...
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Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.
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| 45 | 2021-01-14 | pain |
Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second ...
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Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
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| 45 | 2021-01-14 | dizziness |
Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn...
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Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn't been great
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| 45 | 2021-01-14 | weakness, pain |
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fat...
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Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-01-14 | dizziness |
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati...
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Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
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| 45 | 2021-01-14 | tingling, numbness |
Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and f...
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Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
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| 45 | 2021-01-14 | dizziness, pain, pain in extremity |
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve...
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Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
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| 45 | 2021-01-14 | pain in extremity |
Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared ...
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Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared to left. Carpal tunnel pain at wrist. Worse at night and when holding arm in downward position. Have not had carpal tunnel before. No injury to arms. No recent trauma or heavy lifting
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| 45 | 2021-01-14 | pain |
fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare profess...
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fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare professional reporting for self. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Jan2021 at 12:00 PM (Dose 1) as a single dose in the left arm (age at vaccination: 45 years old) for COVID-19 immunization. There was no relevant medical history. She did not have COVID prior to vaccination. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported; there were no other medications taken in the 2 weeks prior. The patient received the COVID vaccine at 12:00 PM on 02Jan2021. Exactly 12 hours later, on 03Jan2021 at 12:00 AM, she began having a fever, body aches, and severe nausea. This had continued all week. The patient was COVID tested post-vaccination on 04Jan2021 via nasal swab with a negative result. "Yesterday" (as of 08Jan2021) she went to immediate care (physician office) and the doctor said that she had a bad reaction to the vaccine and shouldn't be having fevers every day and if they continue she may need to go to the emergency room. She was tested for other illnesses and everything was negative. Therapeutic measures were taken as a result of severe nausea and included ondansetron (ZOFRAN). The outcome of the events fever, body aches, and severe nausea was recovering. She reported the events as non-serious and confirmed there was no hospitalization. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 45 | 2021-01-14 | pain in extremity |
wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feel...
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wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested
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| 45 | 2021-01-15 | dizziness, pain |
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection...
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Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
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| 45 | 2021-01-15 | weakness, pain |
On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt fe...
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On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt feverish but no fever, achy, headache, weak it felt like I had the flu it lasted 3 days. Telehealth appointment with my doctor 1/12/2020
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| 45 | 2021-01-16 | weakness, pain in extremity, feeling cold |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-16 | dizziness | Vomiting, dizzinesz |
| 45 | 2021-01-17 | dizziness | 5min after vaccine became tachycardic with blurred vision and felt like she was going to pass |
| 45 | 2021-01-17 | tingling, numbness |
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af...
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Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
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| 45 | 2021-01-19 | tingling |
1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itchin...
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1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itching all through body that comes and goes. Could this be delayed reaction to vaccine? highly concerned about getting 2nd vaccine.
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| 45 | 2021-01-19 | pain in extremity |
12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion w...
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12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion with cough. HD tested for Covid 19 (negative on 1/1/21) Started aka seltzer cold and flu medicine, seen in respiratory clinic on 12/31 - started new meds codeine with guaifanesin cough syrup, Flovent inhaler, and Mucinex Max strength cold and flu. 1/8/21, felt more fatigued and cough felt more violent. Seen again in respiratory clinic 1/11/21 negative chest X-ray and Covid 19 test, continue same regimen - rest, OTC, inhalers. 1/20/21, first day of feeling overall improvement, still ongoing cough.
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| 45 | 2021-01-19 | pain |
1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (...
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1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (both not as severe as 1st dose), two days post injection = painful and swollen right axilla lymphadenopathy and right breast pain...used right deltoid for injection site. Also, noted fatigue and chills w/o known fever.
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| 45 | 2021-01-19 | tingling, dizziness, numbness |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-19 | pain |
Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at...
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Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at 2am (approx 14 hrs after injection), took 1000mg ibuprofen w water, sleep. Woke up w L eye swelling (have photos), appears L sinus inflamed, more ibuprofen. Effects continued into Sunday, relieved w ibuprofen, swelling of eye went down. Remained tired and achy throughout Monday 01/18 and Tuesday 01/19, woke up Wednesday 01/20 w L sinus stuffiness and "full" feeling, feels like a 1 sided sinus infection.
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| 45 | 2021-01-19 | weakness | Hives around the waist, weakness/ tired at 0500 1/20 |
| 45 | 2021-01-19 | pain |
Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasti...
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Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasting less than 12 hours.
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| 45 | 2021-01-19 | dizziness | Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm |
| 45 | 2021-01-19 | weakness, dizziness |
Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 11...
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Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
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| 45 | 2021-01-19 | numbness, dizziness |
Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the ...
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Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the dose. Symptoms completely resolved after diphenhydramine within 75 minutes. Patient signed out against medical advice.
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| 45 | 2021-01-19 | weakness, pain, numbness, tremor |
Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had n...
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Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days. Had intermittnet seizure type episodes. Has had labs and imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21. As of 1/20/21 feeling better but still weak.
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| 45 | 2021-01-19 | pain | Swelling of face and pain with stiffness of neck muscles |
| 45 | 2021-01-19 | dizziness |
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro...
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a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
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| 45 | 2021-01-19 | numbness, tingling |
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue are...
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pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
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| 45 | 2021-01-19 | dizziness |
pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine....
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pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.
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| 45 | 2021-01-21 | pain, pain in extremity | Fever , severe chills , body aches , abdominal pain , arm pain |
| 45 | 2021-01-21 | vertigo, pain in extremity |
R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Foll...
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R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Following day, r arm sore, fatigue sinus pressure continued. After second day, no more fatigue, sinus pressure but developed vertigo with nausea, vomiting and diarrhea.
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| 45 | 2021-01-24 | tingling |
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m...
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About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
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| 45 | 2021-01-24 | tingling, pain in extremity, weakness, pain, dizziness |
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,...
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I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
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| 45 | 2021-01-24 | pain, numbness, pain, numbness |
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod...
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She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
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| 45 | 2021-01-24 | pain |
Symptoms started 6-10 hours after receiving my second vaccine dose. Symptoms included, malaise, head...
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Symptoms started 6-10 hours after receiving my second vaccine dose. Symptoms included, malaise, headache, body aches and fatique. Symptoms resolved after approximately 30-36 hours.
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| 45 | 2021-01-24 | pain in extremity |
Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours...
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Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
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| 45 | 2021-01-25 | feeling hot, pain in extremity, weakness |
I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating a...
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I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating and getting really hot. I felt like I might need to use the restroom (soon) and I was at the grocery store. So, I immediately left. My house is 5-7 minutes from the store. During this time, I experienced terrible pains in my stomach and lower abdomen. I barely made it through my door and had to run to my bathroom. I experienced diarrhea like I?ve never experienced in my life. It was painful and explosive. This lasted about 30 minutes on and off. Mostly on. Once I cleaned myself up, I was very tired and weak. I felt nauseous this entire night but have not had any other episodes. I also have not invested anything except water since this happened.
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| 45 | 2021-01-25 | dizziness, feeling cold |
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out...
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Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
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| 45 | 2021-01-25 | vertigo | Moderate vertigo |
| 45 | 2021-01-25 | dizziness |
Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for...
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Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for 30 min to monitor for reaction. After 5 min, patient reported feeling dizzy, tongue feeling slightly swollen, chills, slight difficulty swallowing her own saliva. She denied difficulty breathing, racing heart. NP on site notified, who performed a focused assessment and administered 50 mg IV Benadryl IM. Patient was reassessed and monitored by NP and two RN. Patient reported instant symptom relief within 2-4 min, that her chills went away and no issues swallowing and felt "90%" better. After 15 mins patient reported she was feeling symptoms again come back. Patient was escorted to the ED with NP and RN immediately.
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| 45 | 2021-01-26 | weakness, pain | Fever ranging from 102-104, headache, fatigued, weak, body aches |
| 45 | 2021-01-26 | weakness, migraine |
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I w...
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I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine. About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36 hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
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| 45 | 2021-01-26 | dizziness |
Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR ...
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Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR 66 bpm. Given apple juice and didn't feel lightheadeness or tnling. Then expressed waves of episodes reported by the patient. Monitored for 117 minutes. PRovider called 1 hour after monitoring symptoms that were not worsening. Still felt shakey. Given option to go to ED or be transported by ambulance. Went via ambulance to ED. Did not receive any additional treatment in the ED. ED noted that it did not appear to be anaphylactic reaction.
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| 45 | 2021-01-26 | numbness, pain in extremity |
Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in a...
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Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in arm. Pt still having Anxiety.
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| 45 | 2021-01-26 | dizziness, pain |
headache; aches all over my body similar to how you feel with the flu; aches all over my body simila...
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headache; aches all over my body similar to how you feel with the flu; aches all over my body similar to how you feel with the flu; very tired for 2 days; One week after the second shot I felt dizzy on two occasions; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose on the left arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 on 22Dec2020 09:30 at right arm for COVID-19 immunization and experienced headache and mild arm soreness. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After the second shot by 12:00, patient had a headache, in the middle of the night on 05Jan2021 patient started with aches all over her body similar to how you feel with the flu. The aches lasted for 2 days. Patient was also very tired for 2 days. One week after the second shot she felt dizzy on two occasions. No treatment received. Outcome of the events was recovered in Jan2021. Information about lot/batch has been requested.
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| 45 | 2021-01-26 | dizziness |
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p...
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intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | pain |
joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irrita...
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joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | pain in extremity |
mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable ...
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mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 22Dec2020 09:30 at single dose on the right arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After first shot given at 09:30 by 12:00, patient had a headache and mild arm soreness that lasted a few days. No treatment received. Outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-27 | dizziness, pain |
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad...
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5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
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| 45 | 2021-01-27 | pain, dizziness |
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patie...
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COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
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| 45 | 2021-01-28 | pain |
26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th...
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26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th January 2021-Chills, nauseated 28th January 2021-Body aches, left deltoid area extra tender, nauseated, HA, she has a history of migraines 29th January 2921-A lot better today she took Tylenol for her symptoms-told to go to the ER if her symptoms get worse, PCM if she needs to
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| 45 | 2021-01-28 | dizziness | feeling of throat closing/HTN/drop in O2 sat, itchy throat dizziness |
| 45 | 2021-01-28 | tremor |
severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report f...
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severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself. A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-31 | pain in extremity, pain |
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an...
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nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
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| 45 | 2021-02-02 | weakness, pain |
Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in...
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Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.
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| 45 | 2021-02-02 | dizziness |
Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for parame...
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Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for paramedics who took her blood pressure having 80/50, Patient recovered, felt better and didn't wanted to go to the hospital.
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| 45 | 2021-02-03 | dizziness |
impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more...
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impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-02-03 | pain in extremity, pain | sore arm, fatigue, body aches Narrative: |
| 45 | 2021-02-04 | dizziness |
Patient states that her physician advised against second dose. She states she had a severe headache ...
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Patient states that her physician advised against second dose. She states she had a severe headache for days following vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.
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| 45 | 2021-02-07 | dizziness |
Monitor 9RN) checked on pt at 15 min check. Pt stated to RN that she was feeling warm, lightheaded ...
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Monitor 9RN) checked on pt at 15 min check. Pt stated to RN that she was feeling warm, lightheaded and slightly dizzy. POD leader + supervisor was informed. Supervisor informed EMS staff of current situation. Pt was monitored for 15 min more at that time water was given + vitals were taken. BP 140/75, HR 105,SPO2 94% RA & 20 respirations. 09:15 Pt reassessed by (RN) & (EMS), pt showed no changes, and stated that she felt the same. Pt was removed to a private area to be further evaluated and await until squad arrived. Pt. also stated to staff that she typically experiences these symptoms whenever she takes in any form of nuts. Pt stated she does have an epipen injection. 0922 squad arrived. BP 148/90, HR 83, SPO2 99% RA, RR 20. Pt lung sounds were clear stated by EMS staff. Pt refused to be rescue by squad/ EMS but instead taken by her husband. Pt was informed that if anything went wrong on her way to TCH to call 911 right away. Pt agreed and was discharged at 0921AM.
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| 45 | 2021-02-08 | dizziness |
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva...
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faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-09 | pain, tremor, weakness | tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues |
| 45 | 2021-02-12 | pain in extremity |
Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profoun...
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Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.
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| 45 | 2021-02-14 | pain, pain in extremity, tingling |
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba...
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passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-17 | lightheadedness |
Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood oc...
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Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.
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| 45 | 2021-02-18 | difficulty speaking, inability to speak |
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi...
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Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
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| 45 | 2021-02-21 | feeling hot |
Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), ...
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Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.
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| 45 | 2021-02-21 | swollen extremities, pain in extremity, dizziness |
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da...
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Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
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| 45 | 2021-02-22 | vertigo | Nausea, vertigo, ataxia, falls, change in vision persisting currently |
| 45 | 2021-02-22 | pain | fever, chills, joint pain, nausea, headache, overall pain, insomnia |
| 45 | 2021-02-23 | pain, dizziness |
3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood ...
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3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood pressure & heart rate, dizziness, complete fatigue and meltdowns and very high blood glucose . This lasted till 2/20 until around 5:30 pm
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| 45 | 2021-02-23 | tremor, pain, dizziness |
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo...
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Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-02-28 | pain, dizziness |
Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a cont...
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Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: El9262, via an unspecified route of administration on 26Jan2021 15:00 at single dose in the left arm for COVID-19 immunization. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: En1686 on 05Jan2021 15:15 in the left arm. Medical history included allergy to bacteria. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), bupropion, escitalopram oxalate (LEXAPRO), lorazepam and paracetamol (TYLENOL). The patient previously took erythromycin and experienced drug allergies. The patient experienced fatigue, chills, severe aches, everywhere, headache, nausea, dizziness on 26Jan2021 at 22:00. No treatment received for the events. The patient had no prior vaccinations and has not tested for COVID post vaccination. The outcome of the events was not recovered.
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| 45 | 2021-03-01 | weakness |
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s...
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Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
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| 45 | 2021-03-02 | dizziness |
dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable heal...
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dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 14Jan2021 at 12:30 PM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 26Dec2020 at 03:30 PM (at the age of 45 years old) at the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 16Jan2021 at 09:00 AM, the patient experienced dizziness and achiness behind her eyes for 16 days. The patient did not receive treatment for the events. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab: Negative on 31Jan2021. The outcome of the events was not recovered.
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| 45 | 2021-03-02 | pain |
had mild symptoms chills; body ache; This is a spontaneous report from a contactable nurse (patient)...
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had mild symptoms chills; body ache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 29Jan2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in April2020 and a positive COVID-19 test on 28Jan2021. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced mild symptoms, chills and body aches. On Saturday (30Jan2021) the patient didn't go to work. The patient was concerned because she found out after receiving the vaccine that she had COVID-19 when she received the vaccine. She wanted to know if there were any issues regarding her health with being positive and having gotten the vaccine. The outcome of mild symptoms, chills, and body aches was recovered on Sunday (31Jan2021). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-03-04 | pain |
Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats a...
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Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 45 | 2021-03-04 | pain, dizziness |
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ...
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rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-03-07 | pain in extremity |
arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is ...
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arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 45 | 2021-03-07 | balance disorder, numbness |
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti...
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groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
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| 45 | 2021-03-07 | difficulty speaking |
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S...
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thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
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| 45 | 2021-03-14 | pain |
being sleepy; tired; Body aches; low grade temperature; This is a spontaneous report from a contacta...
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being sleepy; tired; Body aches; low grade temperature; This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 25Jan2021 at 13:30 (at the age of 45 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Jan2021 at 12:00 (at the age of 44 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient did not experience any adverse events to previous vaccinations. Relevant medical history and concomitant medication were none. On 26Jan2021 in the evening, the patient experienced low grade temperature and body aches. On 28Jan2021, the patient experienced being sleepy and tired than normal. She said the sleepiness and tiredness has not lifted since she got the shot. She also said she gets tired anyway. The events did not result in an ER or physician's office visit. The outcome of the events low grade temperature, body aches, being sleepy and tired was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-03-17 | lightheadedness |
body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health c...
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body rash; tachycardic; near syncope; This is a spontaneous report from a contactable other health care professional (patient). A 45-year old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunisation at the hospital. Medical history included asthma, clotting disorder and allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. However, it was reported that the patient had other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID019 prior to vaccination. The patient experienced body rash, tachycardia, near syncope on 20Jan2021. As a result, the patient went to the doctor office; clinic visit and emergency room/ department or urgent care. The patient received Cortisone injections, oral steroids and antihistamine in response to the events. The events were considered as non-serious by the reporter. The outcome of event recovering. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of bnt162b2 (lot number: el3246, expiration date unknown) on 26Jan2021 at 9:30 AM via an unspecified route of administration on the left arm at a single dose for covid-19 immunization. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information received, the reported serious events of Generalized rash, Tachycardia and Pre-syncope were plausibly consequent to single dose for COVID-19 immunisation. The impact of this report on the benefit/risk of profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2020-12-31 | numbness |
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b...
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Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck Â
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| 46 | 2021-01-01 | weakness, dizziness, lightheadedness |
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv...
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Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
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| 46 | 2021-01-01 | lightheadedness, dizziness |
Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/1...
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Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.
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| 46 | 2021-01-02 | numbness, tingling |
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/20...
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Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
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| 46 | 2021-01-02 | difficulty speaking, pain in extremity, tenderness |
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs...
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Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
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| 46 | 2021-01-03 | numbness, tingling |
After the 15 min monitoring, I went back to work 15 min later. the left side of my face started ting...
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After the 15 min monitoring, I went back to work 15 min later. the left side of my face started tingling which went to a numbing feeling down the left side of my body affecting my neck, shoulder, arm, elbow and up the upper left torso. My face and neck was numb for about 48 hrs and the rest came back to sensation within 24 hrs. D/T the numbness I was admitted into the hospital for a 24hr observation.
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| 46 | 2021-01-03 | dizziness |
Patient was feeling faint and placed on a cot with feet elevated above heart, vital signs were taken...
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Patient was feeling faint and placed on a cot with feet elevated above heart, vital signs were taken. Vital signs were as follows: BP was 109/74, Pulse 61. Provided cool wet cloth and water. Vitals were taken again: BP 120/84 and Pulse 73. Patient was placed in sitting position for 5 minutes, patient fully recovered and released.
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| 46 | 2021-01-04 | pain in extremity |
3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE...
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3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE MY HEAD, SHAMPOO/BRUSH MY HAIR, ETC....
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| 46 | 2021-01-04 | dizziness |
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of...
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Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
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| 46 | 2021-01-04 | dizziness |
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ...
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Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
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| 46 | 2021-01-04 | pain, feeling cold |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | tingling, dizziness |
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi...
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Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-04 | pain in extremity |
Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burni...
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Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
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| 46 | 2021-01-04 | weakness |
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea...
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Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
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| 46 | 2021-01-04 | pain, feeling cold |
chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report...
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chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.
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| 46 | 2021-01-04 | balance disorder, dizziness |
feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting posit...
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feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting position on couch i feel fine. too much movement gets me nausea and feeling light headed
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| 46 | 2021-01-04 | pain | fever, body aches, chills, fatigue |
| 46 | 2021-01-04 | dizziness |
flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (pa...
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flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.
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| 46 | 2021-01-04 | weakness |
tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-lik...
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tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 46 | 2021-01-05 | pain |
12/23: developed soreness 12/30: developed runny nose, congestion, cough 12/31: fever 100 deg F and ...
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12/23: developed soreness 12/30: developed runny nose, congestion, cough 12/31: fever 100 deg F and chills
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| 46 | 2021-01-05 | dizziness, vertigo |
24 hours after receiving COVID vaccine I began having symptoms of vertigo and dizziness in my L ear....
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24 hours after receiving COVID vaccine I began having symptoms of vertigo and dizziness in my L ear. Vaccination was given in the L deltoid.
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| 46 | 2021-01-05 | pain, feeling hot |
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a...
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About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
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| 46 | 2021-01-05 | dizziness | Dizziness, flushing |
| 46 | 2021-01-05 | dizziness, numbness |
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ...
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Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
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| 46 | 2021-01-05 | dizziness, movement disorder |
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not ...
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Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
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| 46 | 2021-01-05 | pain | FEVER , ACHINESS CHILLS SEVERE JOINT PAIN |
| 46 | 2021-01-05 | tingling | Left arm heaviness with tingling. |
| 46 | 2021-01-05 | tremor |
Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms...
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Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.
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| 46 | 2021-01-05 | dizziness |
Patient received COVID-19 Vaccine 12/19/2020 at 7:30 am. Did well during the 15 minute observation ...
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Patient received COVID-19 Vaccine 12/19/2020 at 7:30 am. Did well during the 15 minute observation period. Upon returning home started to experience dizziness. Patient has history of (Persistent Postural Perceptual Dizziness (PPPD and Vestibular migraine.
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| 46 | 2021-01-05 | numbness, tingling |
Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/20...
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Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/2021 starting at 0500, the opposite arm (Right) developed tingling and numbness. Thumb is twitching.
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| 46 | 2021-01-05 | pain |
Received vaccination on right arm, the next morning felt radiating pain up to the neck and behind th...
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Received vaccination on right arm, the next morning felt radiating pain up to the neck and behind the ear. Was temporarily resolved with APAP and Advil
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| 46 | 2021-01-05 | dizziness, feeling cold |
c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to even...
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c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
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| 46 | 2021-01-05 | pain | faver 102, body aches, joint pain after first dose |
| 46 | 2021-01-05 | tingling, numbness, dizziness, weakness |
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he...
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muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
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| 46 | 2021-01-05 | tingling, numbness, pain |
states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually ...
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states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually resulted in an "ache". No muscle weakness. This has since improved.
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| 46 | 2021-01-06 | dizziness, weakness, pain |
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj...
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12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
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| 46 | 2021-01-06 | pain |
Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after ...
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Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after 15 hours but returned within 4-6 hours. Easier to manage on second day with ibuprofen. Loss of appetite and nausea. Compazine taken forever nausea. Currently 50 hours post vaccination, had to miss work due to symptoms. Fever free for 12 hours , co tinge to have loss of appetite and body aches
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| 46 | 2021-01-06 | tingling, dizziness | Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98% |
| 46 | 2021-01-06 | pain | Fever 36-48 hours Headache Chills Nausea Aches/ sore muscles |
| 46 | 2021-01-06 | tingling |
Having pins and needles in left hand, today having it in right hand as well, no treatment at this ti...
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Having pins and needles in left hand, today having it in right hand as well, no treatment at this time still having symptoms this morning at time of report
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| 46 | 2021-01-06 | pain | Headaches, body aches, fever, chills, x3 days |
| 46 | 2021-01-06 | pain in extremity |
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on...
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I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
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| 46 | 2021-01-06 | dizziness |
Patient c/o dizziness about 5 minutes post-vaccination. Denies SOB or CP. Transported to ED by drit...
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Patient c/o dizziness about 5 minutes post-vaccination. Denies SOB or CP. Transported to ED by dritical care transport team where she started to c/o headache upon arrival.
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| 46 | 2021-01-06 | dizziness |
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes...
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Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
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| 46 | 2021-01-06 | dizziness |
Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antie...
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Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antiemetics administered, pt reported feeling better. RX for Medrol Dosepak given.
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| 46 | 2021-01-06 | pain | Received covid shot 1-4-21. Has chills, body aches and runny nose. |
| 46 | 2021-01-06 | pain in extremity |
Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had...
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Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
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| 46 | 2021-01-06 | pain |
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right ar...
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Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
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| 46 | 2021-01-06 | dizziness, pain in extremity | Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours |
| 46 | 2021-01-06 | dizziness, weakness, slurring, pain, tingling, vertigo |
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a...
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Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
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| 46 | 2021-01-06 | dizziness |
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ...
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Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
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| 46 | 2021-01-06 | pain | fever 100.3, lymph pain, body aches |
| 46 | 2021-01-06 | feeling hot, numbness |
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he...
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jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-07 | pain |
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Fa...
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Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
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| 46 | 2021-01-07 | facial paralysis | Headache, Fatigue- on day 2 Bels Palsy- Day 4 |
| 46 | 2021-01-07 | dizziness |
Pt began feeling lightheaded after receiving the vaccine. 1146: 100% 91 132/88 Pt was given water an...
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Pt began feeling lightheaded after receiving the vaccine. 1146: 100% 91 132/88 Pt was given water and asked to drink the whole bottle. Symptoms resolved. 1148 98% 70. 1150 126/84 96% 74
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| 46 | 2021-01-07 | tingling, numbness |
The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pa...
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The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pain. That subsided within a day or two. But I am experiencing numbness and tingling throughout the entire length of my arm. It is not severe and I am still able to conduct my work and daily chores, but it is very concerning to me. It is now 5 days later, and the numbness is not any better. My left pinky finger is the worst out of all of my digits. I'm not sure if they somehow hit a nerve during the injection or if this is a side effect of the shot.
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| 46 | 2021-01-07 | pain, pain in extremity, restlessness, feeling cold |
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co...
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With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
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| 46 | 2021-01-07 | pain in extremity |
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, sli...
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left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
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| 46 | 2021-01-07 | difficulty speaking |
she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratc...
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she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
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| 46 | 2021-01-08 | dizziness, tremor |
01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marath...
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01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marathon in bed) Temp 99.5 9:30PM-Temp of 101 then it went to 102 within an hour. Headache. 10:30 took Tylenol 11:30 Temp 101.5 stopped shaking but still have a temp and muscle aches- probably from the shaking. 12:30 (01/08/2021) Temp 101. Fell asleep 4:30 Temp 100 8:30 Temp 99.5 Still have a headache and muscle pain, and upper back pain Tired, but probably just from roller coaster ride. 01/08/2021 Most of the day and night had low grade fever 99.5-100.7 , headache and sweats 01/09/2021 No Fever, but still have the occasional seats and dizziness
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| 46 | 2021-01-08 | dizziness, pain in extremity | 1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current |
| 46 | 2021-01-08 | pain in extremity, dizziness |
Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizzi...
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Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.
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| 46 | 2021-01-08 | pain | Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache |
| 46 | 2021-01-08 | pain | Headache aches, peeling fingertips Narrative: |
| 46 | 2021-01-08 | numbness |
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating ...
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Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.
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| 46 | 2021-01-08 | pain in extremity |
Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids,...
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Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids, Tylenol and Motrin at home
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| 46 | 2021-01-09 | tingling |
14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, ...
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14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, occasionally trunk
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| 46 | 2021-01-09 | dizziness, feeling hot, difficulty speaking |
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe...
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15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
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| 46 | 2021-01-09 | pain in extremity | Arm soreness, myalgia, fever, fatigue |
| 46 | 2021-01-09 | nerve pain, pain in extremity |
Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injectio...
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Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injection), radiates to the right neck and fingertips. Neuropathic, worse at night. Improves to a 3/10 with ibuprofen. No weakness/sensory loss.
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| 46 | 2021-01-09 | feeling hot |
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con...
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Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
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| 46 | 2021-01-10 | pain in extremity, pain |
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci...
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01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
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| 46 | 2021-01-10 | dizziness, pain in extremity |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-10 | tenderness, pain in extremity |
About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg...
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About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg, from the knee down was very achy, along with some swelling behind my knee. The next morning my leg did not ache but was very tender to touch, swollen and as of today (3 days later) it is still tender and swollen.
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| 46 | 2021-01-10 | pain | Arm soreness for 24 hrs |
| 46 | 2021-01-10 | pain in extremity |
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain...
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Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
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| 46 | 2021-01-10 | tingling | Golf ball size lymph node in left axilla, mild tingling in left arm |
| 46 | 2021-01-10 | dizziness, weakness | Headache, malaise, fatigue, dizziness, weakness, chills and hot flashes |
| 46 | 2021-01-10 | swollen extremities |
Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1...
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Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1 cm out. Warm to the touch. Extensive swelling and lymphadenopathy of the axilla, lateral breast up into the pectoralis muscle and into the latissimus muscle. And I
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| 46 | 2021-01-10 | weakness, migraine, pain | Migraines, body ache, malaise, fatigue, weakness, chills, hot flashes |
| 46 | 2021-01-10 | tingling |
One week after administration, I had sudden onset inability to move left arm. I was transported to E...
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One week after administration, I had sudden onset inability to move left arm. I was transported to ER immediately. Treated, scanned with CT of brain, MRI of brain, c-spine and brachioplexus. In hospital for 2 days and no answers. Still no answers to left arm paresthesia and proprioreceptor deficits. Spreading into left leg and mild systemic symptoms. I have been to the ER, seen by primary physician, Physiatrist and Neurology and Occupational Therapy. I am scheduled for many more appointments and trying to find and answer.
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| 46 | 2021-01-10 | tingling, feeling cold, pain |
Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on...
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Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on Saturday 1/9 after receiving dose#2 of the Pfizer COVID Vaccine on 1/8 24 hours prior. Her temp went up to 100.4. She took Tylenol and motrin with subsequent resolution of symptoms except some slight body aches and the onset yesterday of bilateral stocking like paresthesia in LE's. As the body aches improved, she noticed the paresthesias more although they have lessened somewhat today. No prior history of COVID. Allgergies: NKA Meds: as above SH: Tob: none. ASSESSMENT Vaccine Reaction to COVID. PLAN Follow up with OMS tomorrow or prn.
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| 46 | 2021-01-10 | weakness, pain, migraine, pain in extremity |
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v...
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Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
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| 46 | 2021-01-10 | pain | Severe rigors, chills, arthralgia Fever 104 extreme pain |
| 46 | 2021-01-10 | tingling |
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID...
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The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
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| 46 | 2021-01-10 | lethargy | exhaustion, lethargy |
| 46 | 2021-01-11 | numbness, pain, pain in extremity, tingling |
#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue,...
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#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue, scratchy throat. Over next 2 days pain back of legs, which then evolved into burning and then numbness of palms of hands, soles of feet. Reported to me on 1/8. Over last 3 days, she has had slow improvement with slight tingling and numbness fingers. Over weekend, I had her get tested for COVID - both rapid and PCR neg. She went to ED for testing, and they also ran CT head and labs -- negative. She made appt with neurologist today and will follow up with her PCP. Testing for COVID was to rule out as cause for peripheral neuropathy. Might be due to vaccine vs some other undiagnosed condition including autoimmune. Due to the unique nature of this complaint, may be considered Adverse Reaction
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| 46 | 2021-01-11 | pain in extremity, pain, tingling |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-11 | vertigo | Became Dizzy upon standing to leave |
| 46 | 2021-01-11 | pain | Body aches, chills, feverish feeling, mild shortness of breath, dry mouth |
| 46 | 2021-01-11 | feeling cold, tingling |
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is...
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Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
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| 46 | 2021-01-11 | pain, pain in extremity |
Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral ...
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Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
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| 46 | 2021-01-11 | pain |
Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest u...
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Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
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| 46 | 2021-01-11 | migraine |
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach...
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Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
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| 46 | 2021-01-11 | pain in extremity, numbness | Pain and numbness in her arm, fever |
| 46 | 2021-01-11 | weakness |
Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse e...
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Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse event from COVID 10 Vaccine Dec 21, received COVID-19 Vaccine #1 in right arm lot #EH9899 Dec 23- mild pain in left shoulder, did not do anything that I could pinpoint as the cause of this, no injuries, falls or accidents Dec 24, pain intensified Dec 28, 2020- went to primary MD for exam, gave several medications and ordered an MRI of C-spine which was completed on this day. Dec 29- pain has continued to intensify, now shoulder, and entire left arm. Fingers on left hand intermittently numb except for pointer finger that stays numb, and hand is colder than right hand Dec 29, 2020- results of C-Spine showed no significant issues. Small herniation in one of the disks. Per MD, ?more suspicious of a muscular issue or something external to spine pinching that nerve?. Pain has continued despite medications ordered. Dec 30, 2020 MD referred me to a Neuroversion for pain control. I did not want to go here yet, I wanted to know what was causing the issue, not just treat the pain, decided to wait to make this appointment and instead get an appointment with a Neurologist on Monday due to offices being closed on New Year?s Eve. January 4, 2021 pain, numbness and now weakness have persisted all weekend, appointment with Neurologist scheduled for Tuesday January 5, 2021. January 5, 2021, appointment with Neurologist, suspecting Parsonage-Turner Syndrome. Parsonage Turner syndrome (PTS) is characterized by the sudden onset of shoulder and upper arm pain followed by progressive (worsening over time) weakness and/or atrophy of the affected area. The pain is felt along the path of one or more nerves and often has no obvious physical cause. The network of nerves involved in this syndrome is called the brachial plexus and it controls movement and sensation in the shoulders and arms. The cause is still unknown (idiopathic). However, researchers believe that most cases are due to an autoimmune response following exposure to an illness or environmental factor. Suspected triggers include viral and bacterial infections, surgery, vaccinations, injury, childbirth, strenuous exercise, certain medical procedures, and various health conditions. Treatment is symptomatic and may include pain relievers, corticosteroids and physical therapy.[1][2] January 6, 2021- MRI of left shoulder completed January 8 2021- Follow up of MRI with neurologist. No abnormalities seen on MRI, ruled out any other tumors, or anatomical issues causing pain. Diagnosis Parsonage-Turner Syndrome. Increased dosages of current medications and added another to control nerve pain. January 9, 2021- pain seems to be lessening, numbness and weakness continues January 10, 2021- significant pain returned, numbness and weakness continues. I did get the 2nd dose of the COVID-19 lot # EJ1685 in R arm vaccine today, as MD did not advice against it and I still believe that the vaccine is important.
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| 46 | 2021-01-11 | feeling hot |
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brai...
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Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68, 1440 - pt reports I am feeling better but it does come in waves. chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home. does not live alone.
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| 46 | 2021-01-11 | pain in extremity |
Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right...
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Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right deltoid injection of 2nd dose noticed on 1/12/21 at 05:30 which is 4 days post dose. No advert issues or need for medication treatment.
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| 46 | 2021-01-11 | dizziness, pain in extremity |
Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizzin...
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Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization. Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-12 | pain |
1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache,...
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1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache, fatigue. Took tylenol and slept. Next morning, 1/10/21,w oke up at 10am, fever 102, continued with chills, sweats, body aches, joint pain, headache, fatigue and began with intermittent SOB. Took tylenol and slept most of the day and night. Next day, 1/11/21, temp 100.8, continued with chills, sweats, body aches, joint pain, headache, fatigue, intermittent SOB and chest pain. Continued to take tylenol and alternated with ibuprofen. Rested most of the day in bed. 1/12/21, no fever, intermittent SOB with activity, continue with headache and joint pain. 1/13/21 better today. Continue with intermittent SOB with activity and feel fatigue. No fever.
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| 46 | 2021-01-12 | feeling hot, pain |
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa...
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Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
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| 46 | 2021-01-12 | pain, dizziness | Body aches, joint pain, headache, feeling light headed, intestinal cramping, chills |
| 46 | 2021-01-12 | pain in extremity, pain |
Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for ...
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Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
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| 46 | 2021-01-12 | dizziness |
Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactab...
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Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:15 at left arm, at single dose for covid-19 immunization. Medical history included history of seizure, known allergies: topical Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included (ascorbic acid) (VITAMIN C), (sambucus nigra) (ELDERBERRY), (linum usitatissimum seed oil) (FLAXSEED OIL), (allium sativum) (GARLIC). The patient previously took lamotrigine (LAMICTAL) and known allergies: LAMICTAL. The patient was not pregnant at the time of vaccination. The patient experienced palpitations, chest pressure, lightheadedness and nausea on 23Dec2020 14:15. The patient received Zofran and Meclizine given. Event resulted in: Emergency room. The outcome of the events was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.
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| 46 | 2021-01-12 | dizziness |
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a sho...
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Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
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| 46 | 2021-01-12 | pain in extremity |
Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was fee...
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Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was feeling the area where i got the shot and when i raise my right arm i notice under my armpit is swollen.
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| 46 | 2021-01-12 | tingling |
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin...
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Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
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| 46 | 2021-01-12 | pain | Systemic: Exhaustion-Mild, Systemic: Generalized Body Aches -Mild; symptoms lasted for 0 days |
| 46 | 2021-01-12 | dizziness | Systemic: dizziness, tinnitus, blood pressure 220/112 |
| 46 | 2021-01-12 | dizziness | TIGHTNESS OF CHESS, FEELS LIKE I AM GOING TO GET AN ASTHMA ATTACK. SOME COUGHING DIZZINESS |
| 46 | 2021-01-13 | pain, tingling |
Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday ar...
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Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday around 1130am- went home from work and took ibuprofen. stayed home from work Wednesday- started to taper off pre immunization medication of benedryl, Pepcid, and prednisone on Wednesday afternoon. Wednesday night noticed using my inhaler. Little more- I took Half dose of prednisone. Had to do nebulizer treatment later that night. Thursday morning woke up wheezing took another prednisone and used rescue inhaler. Went to work and wheezing didn?t get any better, but didn?t get any worse. Took another prednisone and sent home to do nebulizer. Continued to rest and monitor asthma- Notified PCP of what was going on- advised to continue Pepcid, benedryl and prednisone for a few more days and advise of any issues.
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| 46 | 2021-01-13 | pain in extremity |
Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contac...
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Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on her left arm on 28Dec2020 at 12:45 at a single dose for COVID-19 immunization. Medical history included hypertension, migraine, polycystic ovaries (PCOS) and allergies to wasp venom and dust mites. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 28Dec2020 at 15:45, the patient experienced mild left arm pain near injection site that lasted a few hours, severe fatigue which started 3 hours post injection and lasted for 4 hours; and moderate headache which started on 29Dec2020 (duration 3 days). The patient did not receive treatment for the adverse events. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-01-13 | pain in extremity |
On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't ...
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On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't put weight on my left foot. Felt like i sprained it. The pain was there for two and a half days and suddenly it went away and i was ok. Now this past sunday January 10th my period came, 15 days earlier, and is really bad. I have to change pads like every two hours because of the amount of blood coming down and is still going on today. It has never lasted this long and I have not bleed this much for this long either.
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| 46 | 2021-01-13 | pain in extremity, pain, migraine |
Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever...
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Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever of 101.6. My right arm is very sore/tender. I have generalized aches.
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| 46 | 2021-01-13 | numbness, pain in extremity |
Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or poppin...
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Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen. The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided. Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy. Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm. Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
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| 46 | 2021-01-13 | migraine |
Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous...
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Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received bnt162b2 (BNT162B2) lot no: RH 9899, via an unspecified route of administration in left arm on 16Dec2020 at a single dose for Covid-19 immunization in hospital. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL), trazodone, and lorazepam (ATIVAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 17Dec2020 06:00, the patient experienced severe, intractable daily migraine headaches that escalate throughout the day and do not respond to any treatment, medicinal or non medicinal (unspecified). The event was reported as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event. The patient received another bnt162b2 dose (lot no: EK 4176) on 06Jan2021 in left arm. Information on the batch number has been requested.
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| 46 | 2021-01-13 | dizziness |
fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizzi...
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fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizziness, slight headache and decreased appetite
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| 46 | 2021-01-13 | pain |
following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflamm...
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following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflammation, overall discomfort, back pain which radiated to the front of the chest lasting x3 days, took Tylenol. now resolved
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| 46 | 2021-01-13 | tingling |
paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from ...
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paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date 30Apr2021) via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine (the last dose of Ibuprofen was two or three days ago before 08Jan2021). The patient had received the first single dose of BNT162B2 on 18Dec2020 for COVID-19 immunization and experienced soreness in the left arm which lasted for a day and a half. No other vaccine received within 4 weeks. The patient experienced paresthesia of the left arm and hand on 08Jan2021. She received the first dose of the vaccine on 18Dec2020 in her left arm and had some soreness in the left arm at that time, which was resolved on 20Dec2020 (event reported in AER 2021019477). On 08Jan2021, she received the second dose also in her left arm and within five minutes she had this strange paresthesia of the left arm and hand. She also described it as strange heaviness of the left arm. No limited range of motion of the left arm. She didn't know if it was serious. She didn't visit emergency room or physician office. After two hours (the time of reporting) she still had the same sensation. The event was not resolved. The reporter considered the event paresthesia of the left arm and hand was related to the vaccine.
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| 46 | 2021-01-14 | tingling |
A few minutes after receiving the vaccine patient developed tingling in all four extremities and st...
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A few minutes after receiving the vaccine patient developed tingling in all four extremities and stated that her lips felt weird
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| 46 | 2021-01-14 | tingling |
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated t...
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A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
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| 46 | 2021-01-14 | pain, weakness | Body ache , feeling weak |
| 46 | 2021-01-14 | weakness, pain |
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird meta...
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Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
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| 46 | 2021-01-14 | feeling hot, pain, tremor |
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ...
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I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
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| 46 | 2021-01-14 | dizziness, numbness, weakness |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-14 | dizziness | Lightheaded, dizzy, nausea, dry mouth, shortness of breath |
| 46 | 2021-01-14 | weakness, pain | Temature, body aches, headache, weak and vomiting |
| 46 | 2021-01-14 | pain | achy, chills, swollen lymph node, tired, headache |
| 46 | 2021-01-14 | feeling of body temperature change, pain in extremity |
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold ...
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arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
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| 46 | 2021-01-14 | pain |
chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous...
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chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162b2 (lot: EL1283), via an unspecified route of administration in left deltoid on 09Jan2021 15:30 at single dose for covid-19 immunization. Medical history included asthma from Dec2019 and ongoing, insomnia, hypertension. Concomitant medication included ongoing hydrochlorothiazide, metoprolol tartrate (LOPRESSOR HCT) for Hypertension. The patient previously took lopressor and experienced edema. The patient previously received the first dose of BNT162b2 (Lot number: EK5730), intramuscularly in right deltoid at single dose on 19Dec2020 for covid-19 immunization. The patient experienced fever, chills, flu like symptoms, headache all day long on 10Jan2021. The above events were reported as serious as medical significant. No nausea or diarrhea. She had chills and was drenched in sweat on 10Jan2021. She woke up at 10:30 am with chills, body aches on 10Jan2021. Last night at 10 pm she finally fell asleep. She woke up this morning (11Jan2021) and felt fine. The outcome of the event sweating was unknown, other events was recovered on 11Jan2021.; Sender's Comments: Based on a close temporal relationship there is a reasonable possibility of an association between the events and the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-14 | pain |
her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain...
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her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 46 | 2021-01-14 | difficulty speaking, lethargy, pain |
severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; i...
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severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.
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| 46 | 2021-01-14 | pain in extremity |
sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a s...
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sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
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| 46 | 2021-01-15 | tremor, feeling cold, dizziness |
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ...
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12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
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| 46 | 2021-01-15 | pain | Injection site pain, headache, body aches, joint pain |
| 46 | 2021-01-15 | pain in extremity |
Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred ...
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Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred since then: extremely itchy blotchy rash that attacked underarms, under bra area, stomach, lower back, legs. Skin was hot to the touch, felt like a mild sunburn, sensitive to the touch, difficulty wearing clothes. Pain in muscles/joints in hands, and knees .
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| 46 | 2021-01-15 | dizziness, numbness, tremor |
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo...
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Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
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| 46 | 2021-01-16 | pain in extremity |
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The h...
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24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
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| 46 | 2021-01-16 | tremor |
Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of n...
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Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of night with 103 fever which lasted 36 hours. SEVERE headache began on Day 2 which I wondered if I should go to urgent care. Unable to tolerate walking or being "up" for more than 3-5 minutes at a time. Notable fatigue. A week later now, still having daily headaches which are moderate in nature.
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| 46 | 2021-01-16 | numbness, pain |
Besides soreness on the injection site on both times, a day after received the second dose of Covid-...
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Besides soreness on the injection site on both times, a day after received the second dose of Covid-19 vaccine I have experienced left-arm site soreness, aches all over my body i.e back pain and muscle pain, malaise, chills, and numbness on the fingers on my left arm.
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| 46 | 2021-01-16 | numbness | Rapid onset facial & neck numbness, headache |
| 46 | 2021-01-16 | tingling, numbness |
This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was fir...
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This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
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| 46 | 2021-01-16 | pain, swollen extremities |
Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday ...
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Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday I woke up with a severely swollen armpit and anterior chest
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| 46 | 2021-01-17 | pain |
12/23 vaccine' 12/27/2020 lower abdominal pain, woke up with symptoms, severe. vomited 1x. Sharp pa...
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12/23 vaccine' 12/27/2020 lower abdominal pain, woke up with symptoms, severe. vomited 1x. Sharp pain. Intermittent. 12/28/2020 pain got less 12/29/2020 referred to pcp. Thought possible ovarian cyst. 12/30 Pain continued, lower abdominal.
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| 46 | 2021-01-17 | pain |
18 hours post injection I started with body aches and chills. No fever. Body aches continued for 12 ...
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18 hours post injection I started with body aches and chills. No fever. Body aches continued for 12 hours. Tylenol and Advil taken with some help. Headache continued off and on for a week.
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| 46 | 2021-01-17 | tingling |
Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe h...
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Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe headache, no breathing difficulty, no rash, no swelling of tongue or throat, was able to walk, now feeling much better- after 2 days.
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| 46 | 2021-01-17 | pain in extremity |
arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contact...
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arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 46 | 2021-01-19 | pain | 100.5-101 Fever x 15 hrs thus far, chills, body aches, headache, fatigue-Ongoing |
| 46 | 2021-01-19 | pain | Fever, chills, body aches |
| 46 | 2021-01-19 | pain, tingling, pain in extremity, feeling of body temperature change |
Hello, When I received my second Covid vaccine, I was asked to report my side effects to this emai...
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Hello, When I received my second Covid vaccine, I was asked to report my side effects to this email address. They are as follows: After Vaccine 1 (12/22/20): I had the vaccine at around 1:30pm. I only had arm-stiffness at first. Approx. 24 hours after however (1:30pm the next day), I started having chills and feeling like I had a fever. My entire body ached but I did not have a headache. These side effects lasted through the night for approx. 14 hours. The following day I woke up with a surge of energy and felt very much like I had been given a shot of adrenalin. I?m not sure that I have ever felt as good. After Vaccine 2 (01/11/21): I had much more severe side effects after the second vaccine. I had this vaccine at approx. 1:30 pm and within a couple of hours I started to feel a bit tired. At approx. midnight that night, I started having body aches and a headache that woke me up. I had chills and was oscillating between feeling very cold and feeling very hot. Through the night I had to change my clothing several times due to sweating. These symptoms lasted for the entire following day. The second day after the vaccine I felt much better but still a little tired. Of greatest concern is that I have a lingering pain deep within my left arm (the arm into which the shots were given). Having a hard time extending my arm and doesn;t seems to be going away. Sometimes it feels tingly and I sometimes have loss of grip and/or weakness in the entire arm. Hope this helps you in compiling the side effects. Thank you.
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| 46 | 2021-01-19 | difficulty speaking |
I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visibl...
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I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visible muscle spasms, and my teeth began to chatter uncontrollably.
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| 46 | 2021-01-19 | tingling |
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min...
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Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
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| 46 | 2021-01-19 | tingling |
suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; ...
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suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-19 | pain in extremity |
the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen...
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the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen lymph node near her collar bone
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| 46 | 2021-01-20 | pain |
COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contac...
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COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (Lot Number: EL1284), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID test/ tested positive on 29Dec2020, chills, body aches on 25Dec2020. She was supposed to get the second dose of the COVID Vaccine at the time of this report. She got the first dose on 23Dec2020 and after 2 days got chills and body aches. She took a COVID test swab on 29Dec2020. Then she tested positive on 31Dec2020. She was asymptomatic besides chills and body aches. She was in Isolation for 14 days and is done. She was wondering if she could take the second dose. Caller was a nursing assistant. The patient underwent lab tests and procedures which included COVID test swab: positive on 29Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID test swab positive) with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-21 | numbness |
1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well ...
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1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well she could leave. Patient stated she had had some left lateral hand numbness since just after the injection that now is feeling more like tightness than numbness, a new tickle in the throat and tongue which felt "puffy" like "taking up some more space than normal. Denied any other symptoms. 1400: VS 135/90, pO2 98-99%, HT regular at 84, stated throat tickle dissipating, tongue puffiness resolving and left had less tight. 1410: Patient asked to go to BR and returned without complaint. 1420: Patient drank small bottle of water without difficulty, "felt normal to swallow." Patient stated her symptoms had resolved and there were no new symptoms. Patient stated she felt normal and comfortable to drive home.
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| 46 | 2021-01-21 | pain in extremity |
8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlar...
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8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlarged, and right breast pain and swelling started. Symptoms impeded function of arm. Seen by a provider on 1/19/2021
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| 46 | 2021-01-21 | dizziness |
Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but ...
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Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but felt intermittently clammy/sweaty started on the 20th and resolved midday on the 21st until the morning of the 22nd, the dizzy/nausea returned and occasional sweaty/clammy feeling. Called OHS and they recommended calling pcp. PCP called in script for zofran and instructed me to take that and dramamine and call if not improved by Monday the 25th
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| 46 | 2021-01-21 | dizziness, numbness |
Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered set...
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Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
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| 46 | 2021-01-21 | pain in extremity |
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to...
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I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
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| 46 | 2021-01-21 | pain in extremity |
My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after gett...
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My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after getting the vaccine. There was initial soreness that I expected but its more than 2 weeks past now and now I do not want to receive my 2nd dose on 1-26
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| 46 | 2021-01-21 | numbness |
Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of f...
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Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
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| 46 | 2021-01-21 | tenderness |
On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side ...
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On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side wit ear and base of neck was tender and painful to touch. Client has been taking tylenol, lemon candy lozenges, hot packs, and herbal tea. These have provided short periods of relief.
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| 46 | 2021-01-21 | feeling hot |
Shortly after the vaccination I got a burning warming sensation up and down my left leg which still ...
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Shortly after the vaccination I got a burning warming sensation up and down my left leg which still presist today. I had a fever for one day but had diarrhea for about a week.
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| 46 | 2021-01-24 | dizziness |
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous...
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Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
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| 46 | 2021-01-24 | tremor, dizziness |
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we...
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I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
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| 46 | 2021-01-24 | pain in extremity, pain |
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank...
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Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
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| 46 | 2021-01-24 | feeling hot |
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m...
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Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
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| 46 | 2021-01-24 | pain |
chills; extreme fatigue; fever of 102.9 for 12 hours; body aches; headache; This is a spontaneous re...
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chills; extreme fatigue; fever of 102.9 for 12 hours; body aches; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot EL1284) intramuscular in Left arm on 11Jan2021 at 18:00 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, endometriosis, polycystic ovarian syndrome (PCOS). Known allergies to latex, and past drug allergy to levothyroxine and armour thyroid. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EH9899) on 21Dec2020 at 18:00 intramuscular in Left arm at single dose for COVID-19 immunization.The patient's concomitant medications were not reported. On 12Jan2021, within 24 hours of her second COVID-19 vaccination, the patient started with chills, then fever of 102.9 for 12 hours, extreme fatigue and body aches, when fever broke the headache started. She was feeling better by the following morning, so it was approximately 24 hours of symptoms that started approximately 24 hours after the 2nd vaccine. The final outcome of the events was reported as recovered on 13Jan2021, without treatment administration.
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| 46 | 2021-01-24 | pain, feeling of body temperature change, tremor |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-24 | pain |
on Jan 9-11 experienced significant muscle fatigue Jan 12-17 body aches, headache requiring over the...
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on Jan 9-11 experienced significant muscle fatigue Jan 12-17 body aches, headache requiring over the counter NSAID for some relief Jan. 18 to present, mild symptoms of headache, muscle fatigue persist although not as severe
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| 46 | 2021-01-25 | pain |
Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report f...
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Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 10:30 on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on an unspecified date. The patient experienced extreme body achees, severe headache, lymphadenopathy in the armpit, all at 21:30 on 11Jan2021. Adverse reactions did not result any serious consequences. Facility type vaccine was hospital. No need treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Other medical history was none. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 46 | 2021-01-25 | weakness, pain, tremor, lethargy |
Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in ...
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Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in the armpit of the injection arm; severe sore throat; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown), intramuscular in the left arm on 08Jan2021 at 08:30, at a single dose, for COVID-19 immunisation. Medical history included autoimmune disease. The patient has no know allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown), intramuscular in the left arm on 18Dec2020 at 08:00 AM for COVID-19 immunisation. On 08Jan2021, at 15:00, the patient experienced fever, chills, aches and pains, lethargic, shaking, weakness, sweats, joint pain, headache, pain in the armpit of the injection arm, severe sore throat, and generally feeling ill. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient underwent nasal swab on 10Jan2021 with a negative result.
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| 46 | 2021-01-25 | pain |
On 1/22, two days after injection of 2nd dose, recipient developed diarrhea, nausea, aches which per...
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On 1/22, two days after injection of 2nd dose, recipient developed diarrhea, nausea, aches which persisted for 48 hours.
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| 46 | 2021-01-25 | weakness, dizziness, pain in extremity |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-25 | pain |
cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a cont...
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cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
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| 46 | 2021-01-26 | pain |
Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; bac...
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Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
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| 46 | 2021-01-26 | pain |
Fatigue within a few hours of receiving vaccine. Extreme fatigue the next day, as well as body aches...
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Fatigue within a few hours of receiving vaccine. Extreme fatigue the next day, as well as body aches and headache. That evening fever onset and chills.
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| 46 | 2021-01-26 | tingling | Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0 |
| 46 | 2021-01-26 | tremor |
Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day ...
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Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day of 1/19, only took 1g dose of Tylenol that evening mostly due to headache. I woke up feeling fine on 1/20 but then developed some shakiness that evening. On 1/21, I had fatigue/tiredness, and other than food/bathroom, stayed in bed resting. On 1/22 continued to feel fatigued and dizzy, finally checked my BP, the readings were 93/67 (did not write down HR - heart rate) and 89/68, HR87. I videoconferenced the Methodist urgent line, spoke to NP, recommended continued check BP and increase fluid intake. Still feeling slightly dizzy and tired, but better overall, just feel slightly "off", especially with exertion. BP: 1/23 - 98/76 HR84 , 104/83, HR77; 1/24 - 102/82, HR87; 1/25 - 109/75, HR68, 104/67, HR58, 98/79,HR104, 96/74, HR93; 1/26 - 94/69, HR81, 95/72, HR74, 98/64, HR80; 1/27 - 121/84, HR81 (during MD video visit), 114/80, HR75, 96/74, HR82. Spoke to my doctor today. She asked if I'd filled out this form so decided to fill out. She recommended I continue to monitor BP, increase fluid intake, restart vitamins, add electrolyte drink, add caffeinated drink (for intermittent headache) and follow-up next week if not resolved.
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| 46 | 2021-01-26 | numbness, tingling |
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ...
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the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
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| 46 | 2021-01-26 | dizziness |
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizzine...
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tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-28 | pain | Fever, body aches |
| 46 | 2021-01-28 | dizziness |
Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated...
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Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.
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| 46 | 2021-01-28 | tingling, dizziness, feeling hot |
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ...
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pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
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| 46 | 2021-01-31 | pain |
Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactab...
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Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek9213), via an unspecified route of administration at the left arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included diabetes, psoriasis, asthma and Covid (prior vaccination), all from an unknown date and unknown if ongoing. The patient was not pregnant. The patient had no known allergies. The patient's concomitant medications were not reported. On 16Jan2021 07:00, the patient experienced injection site pain, headache, body aches and joint pain. No treatment was received. There was no other vaccine in four weeks. The patient has not had covid tested post vaccination. The outcome of the events was recovering.
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| 46 | 2021-01-31 | pain in extremity |
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee...
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severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
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| 46 | 2021-02-03 | tingling |
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te...
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Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
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| 46 | 2021-02-04 | tingling, tremor |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-08 | inability to speak |
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w...
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One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
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| 46 | 2021-02-11 | feeling hot, pain in extremity, pain |
within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Ha...
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within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Hard to walk. progressivly got worse to point unable to walk without pain, lay down without pain. only able to sit. Steroids, NSAIDS, ICE, Whirlpool Therapy, message, chiropractor. Neurologist consult unable to walk. 2/1/21 MRI completed Circumferential disc bulge with superimposed left lateral recess and foraminal disc protrusion at L4-5 resulting in moderate to severe left foraminal stenosis and impingement of the exiting left L4 nerve root. There is contact of the traversing bilateral L4 nerve roots with some mass effect on the traversing left L5 nerve root. Correlate for left L4 and/or L5 radiculopathy. Â 3. Circumferential disc bulge with superimposed right lateral recess and foraminal disc protrusion at L2-L3 with contact the traversing right L3 nerve root, but no nerve root compression. No compression of the exiting right L2 nerve root. Correlate for right L3 radiculopathy It is my impression that patient presents with acute onset of left L4 radiculopathy. Her MRI scan suggests a far lateral/foraminal left L4-L5 disk herniation. She also has some underlying lateral recess stenosis which is fairly mild. Â I discussed the above findings with patient and her husband. I reviewed her MRI scan with the help of a spine model. I outlined both conservative and surgical approaches. However, given her findings and the severity of her pain currently, I think one could argue that a left L4-L5 microlumbar diskectomy via far lateral approach would be her most definitive option. I did outline this procedure in detail with the help of a spine model. I outlined the risks which include but are not limited to infection, bleeding complications, nerve root and/or cauda equina injury, cerebrospinal fluid leak, recurrent disk herniation, spinal instability, the possibility that she could require additional spine surgery in the future, and the possibility that her would not be relieved to her satisfaction. We also discussed trying a left L4-L5 foraminal steroid injection but she has had injections in the past and she actually felt like it gave her more pain. At this point she would like to go ahead and schedule the left L4-L5 microlumbar diskectomy via far lateral approach with METRx. This will be scheduled on an elective basis in the near future.
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| 46 | 2021-02-18 | weakness |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-19 | vertigo |
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ...
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24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
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| 46 | 2021-02-21 | migraine |
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC...
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- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
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| 46 | 2021-02-21 | tenderness | 40-60 tender red bumps, mostly on torso. |
| 46 | 2021-02-21 | dizziness |
Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and...
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Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and headache. Patient denied difficulty breathing or swallowing. Denied chest pain or palpitations. Patient reports dizziness began 3 weeks ago. Glucose was 167.
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| 46 | 2021-02-21 | speech disorder, dizziness, pain |
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ...
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Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
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| 46 | 2021-02-22 | dizziness |
C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight...
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C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
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| 46 | 2021-02-22 | pain in extremity |
Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, aff...
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Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, affected work.
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| 46 | 2021-02-22 | pain |
Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Da...
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Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Day 4-5: felt completely fine Day 5-6: that evening, all of the same symptoms returned, including fever of 102 Day 7-9: felt completely fine Day 10-11: all symptoms returned, including fever of 101 Day 12: today, feel completely fine
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| 46 | 2021-02-22 | tremor, pain |
Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches...
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Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches, body aches, and muscle pain.
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| 46 | 2021-02-22 | pain, pain in extremity | Pain in arm, upper body aches, back, neck, shoulder, headache sore throat, congestion. |
| 46 | 2021-02-22 | pain in extremity |
Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 ho...
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Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
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| 46 | 2021-03-01 | feeling cold, tremor, pain in extremity |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-02 | pain |
Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid...
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Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and expiration date not reported), intramuscular administered to left arm on 04Jan2021 14:00 for COVID-19 immunization. Vaccination Facility Type: Hospital. Medical history included migraine. Patient had medication for them, but has not had any migraines in a long time. The patient's concomitant medications were not reported. There were no other vaccines given the same day. Patient had no problems with vaccines in past. The patient had questions about the side effects of the Covid vaccine. On 04Jan2021 when she got the first dose, later that day (a few hours after the shot) the patient experienced flu like symptoms (body aches, headache, muscle aches, and light fever). Had the headache for about 4 days with the first dose. All this lasted about 4 days. They cleared up and she was fine. The patient wanted to know if anyone reported any of this or prolonged symptoms. Patient was unable to provide seriousness criteria when queried, only states that it was very frustrating, it's not life threatening, but she was at home versus being at work. No investigation assessment/relevant tests performed. The patient recovered from the events on an unspecified date in Jan2021. The reporter considered the events as related to the Covid vaccine. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
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| 46 | 2021-03-02 | involuntary muscle movements, dizziness |
Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received fro...
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Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine and gabapentin. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 24Dec2020, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 13Jan2021, the patient experienced gait issue, involuntary lips movement, dizziness and fatigue. No treatment was given for the events. The outcome of the events was not recovered. Information about lot/batch no. has been requested.
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| 46 | 2021-03-02 | pain, lethargy |
body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight ...
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body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight throbbing in head/throbbing in head became much worse by midday; very tired; body chills and hot sweats on and off; body chills and hot sweats on and off; still lethargic and achy but improving; slept all day, and all night; eye pain which was triggered by light and eye movements; eye pain which was triggered by light and eye movements; This is a spontaneous report received from a contactable nurse (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 11:15, at single dose, for COVID-19 immunization, at an urgent care center. There was no medical history. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included probiotics. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 08Jan2021 11:15, for COVID-19 immunization. On 30Jan2021 at 07:00, the patient experienced body aches and slight throbbing in head which became worse by midday; was very tired; returned to bed within 30 minutes and slept all day, and all night; had eye pain which was triggered by light and eye movements; body chills and hot sweats of and off. The patient reported that although she never had a fever according to her non contact forehead thermometer, she had body chills and hot sweats on and off. 48 hours later, she was still lethargic and achy but improving. Treatment for the events included ibuprofen 600 mg every 4-5 hours which helped but did not completely relieve the discomforts. The patient was recovering from the events.
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| 46 | 2021-03-02 | migraine, tingling, pain, numbness |
migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fe...
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migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fever; body aches and muscle aches; body aches and muscle aches; really sick; She had the horrible headaches; Nausea; Upset stomach; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization and experienced flu like symptoms, body aches, headache, muscle aches and light fever. No additional vaccines administered on the same date of the Pfizer suspect. The patient had questions about the side effects of COVID vaccine. The patient experienced migraine, face numb and tingling sensation, vomiting, diarrhea, fever, body aches and muscle aches, and has been really sick the night after that second vaccine on an unspecified date in Jan2021. It is slowly getting better and now it had been a Monday a week later from the second dose and she still has the body aches, fever that comes and goes, and headaches that have just been ongoing. She wanted to know if anyone reported any of this or prolonged symptoms. She also mentioned horrible headaches, nausea, vomiting, numbness and tingling in face on an unspecified date in Jan2021. She mentioned again the nausea and upset stomach, body and muscle aches and fever she still has a little of on an unspecified date in Jan2021. The biggest thing was the headaches. The body and muscle aches and fever comes and goes. Thought she was over the fever and it started back again yesterday. She was unable to provide seriousness criteria when queried, only stated that it was very frustrating, it's not life threatening, but she is at home versus being at work. The events migraines, fever off and on, body and muscle aches, diarrhea, vomiting, numbness and tingling in face, really sick required a visit to the Physician office. The outcome of the events migraine, Tingling, Numbness in face, Vomiting, Diarrhea, Fever, Generalized aching, Muscle ache and sickness was not recovered while the outcome of the events headache, nausea and upset stomach was unknown.
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| 46 | 2021-03-04 | pain |
body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-conta...
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body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-contactable consumer who reported for herself. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 01Feb2021 01:15 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination and patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 12Jan2021 03:15 PM for COVID-19 immunization. On an unspecified date, the patient experienced body aches, chills, pain at injection site and tiredness. No treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-03-09 | tingling, numbness |
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything...
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The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
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| 46 | 2021-03-09 | pain in extremity |
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ...
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got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
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| 46 | 2021-03-15 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-ol...
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Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on 01Mar2021. The event was reported to have resulted in emergency room/department or urgent care visit. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the known safety profile of the COVID-19 vaccine, and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported bell's palsy and the suspect administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 46 | 2021-03-15 | dizziness |
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl...
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First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
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| 46 | 2021-03-18 | tremor, feeling cold |
In the first 5 mins after the injection I became very irritable and then within 10 mins had a cold s...
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In the first 5 mins after the injection I became very irritable and then within 10 mins had a cold sensation in my head that I had previously had after a reaction to sulfa and had almost passed out. I told a staff person who had me talk to one of the nurses & put me in a separate space from people getting vaccinated. The nurses then wasted a lot of time talking to me about anxiety instead of treating me. The cold sensation traveled from my head down my neck, there was a sharp pain in my left breast, and then my heart started racing. My lips and tongue on the left side started swelling. I told the nurses this but they ignored me. Eventually they brought in equipment to monitor my vital signs. My blood pressure and heart rate were higher than I had ever seen them and kept rising. The head nurse eventually said I needed medical care & there was no doctor on site. She called the paramedics. It was now 1 hour after I told them something was wrong. The paramedics thought this was temporary because my bp fell to 153 [I told them I did not have a hist of bp this high] from where it had been before & gave me Benadryl pills. (The ER doctor later said they should have done something). Later that night my HR went up to 220 and I was taken to the ER. The ER doctor also wasted time assuming it was anxiety but bloodwork showed I was in shock. They first treated me with 4 aspirin, then Atavan, which all did nothing. My bp was up to 189 the last time I could view the monitor. Sodium chloride ivs, Bendaryl ivs were given after the bloodwork. Diltiazem was eventually also given. I had palpitations that caused my entire body to shake. EKG showed I had developed an atrial flutter and the doctor said the flutter, arrhythmia, and tachycardia were caused by the shock from the vaccine disrupting the electrical signals in my heart. I stayed overnight in the ER until Sat morning. I took Diltiazem but jolting palpitations and tremors did not stop. I saw a cardiologist on the 25th who concluded I had gone into shock from the vaccine, and I was given the wrong medication, and put me on metropolol. Metoprolol lowered my bp and reduced the palpations. I weaned off it with the doctor's permission. I still have palpitations.
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| 46 | 2021-03-18 | pain, tremor, numbness |
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to...
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Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-22 | pain |
Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2...
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Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2 years previous to Pfizer COVID-21 vaccination) recurred after first vaccination, worsened after second vaccination, leading to 2 ER admission and hospital admission. Ultimate cause still not determined or successfully treated; pain continues treated by opoids, gabapentin, anti-nausea medication. Patient has not been able to work since March 4th, 2021 (currently March 23rd, 2021). Details: The day after the first vaccination, abdominal pain similar to that the patient had previously experienced, but which had not presented severely for around a two years, recurred quite severely for 4-5 days. Missed 2 days of work. Pain reduced enough to resume work after 4-5 days. The day after the second vaccine dosage (2 Feb 2021), the abdominal pain worsened again, becoming more severe and more prolonged than after the first dosage. Missed four days of work (not consecutive). Pain worsened. 12 March 2021 visited PCP, who recommended immediate ER/hospital admittance. ER could not any definite cause of pain (though 8cm fibroid present, thought to be causing lower abdominal pain but not upper abdominal) and released patient. Abdominal pain became somewhat better but still continued. March 6th, abdominal pain greatly increased, leading to ER visit and hospital admittance March 6th-March 9th, 2021. CT scan 6 March 2021. Relevant results: Bowel: Multiple dilated loops of distal small bowel with fecalization of small bowel contents and a slow transition to normal caliber at the terminal ileum. The appendix is not visualized. The stomach is unremarkable. The colon is not dilated. Mesentery/Peritoneum: Small indeterminate density fluid adjacent to dilated loops of bowel in the right lower quadrant. Nodes: Scattered small abdominal nodes, none meeting CT criteria for pathologic enlargement. Pelvis: Large uterine leiomyoma. Uterine fibroid identified as probably source of pelvic and lower abdominal pain. Mid and upper abdominal pain thought not to be related, however, and may be related to dilated loops of distal small bowel and adjacent fluid. Pain treated with opoids, gabapentin, anti-nausea drugs, patient released 9 March 2021. Abdominal pain continues, partially controlled with pain medications. Lower pelvic pain has not recurred (birth control pills started at end of hospital visit). Patient has been been able to work since March 4th (currently March 23rd, 2021). Patient is applying for short-term disability due to extended absence from work caused by these issues.
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| 47 | 2020-12-31 | numbness, facial paralysis |
Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then ...
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Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then yesterday 12/31 at 330pm while painting my left face became paralyzed and numb. Went to ER Had CT/CTA of head EKG, chest Xray and multiple labs including Lyme test which will not be resulted for 5-7 days. ER started me on taper prednisone and doxycycline. Diagnose with significant Bell's Palsy
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| 47 | 2020-12-31 | pain, tenderness |
Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp...
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Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp pain to palpation.
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| 47 | 2021-01-02 | dizziness |
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST...
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BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
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| 47 | 2021-01-02 | dizziness, weakness | dizziness weakness headache neck pain |
| 47 | 2021-01-03 | dizziness |
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m...
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12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
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| 47 | 2021-01-03 | inability to speak |
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breat...
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Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.
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| 47 | 2021-01-03 | dizziness |
Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awa...
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Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awake, dizziness subsiding Sat 10am Dizziness Subsiding, general malaise, Nausea Sun Dizziness gone, Runny Nose, Stuffiness, full/congested feeling Mon 99.5, Nausea, Drainage
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| 47 | 2021-01-03 | tingling, pain in extremity |
Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilate...
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Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.
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| 47 | 2021-01-03 | migraine, pain in extremity, dizziness |
Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise ar...
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Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
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| 47 | 2021-01-03 | pain |
have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable c...
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have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable consumer reporting for a patient (nurse). A 47-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 20Dec2020 for immunization. The patient's medical history concomitant medications were not reported (unknown). Patient was an ER Nurse and took first dose of vaccine and then described mild/moderate symptoms on day one only. On 23Dec2020, patient posted they have COVID (positive COVID test). Contracted from spouse who got it from work. She further described it as "hit by a truck." On Day 4 she describes her COVID symptoms: bone-crushing-pain when fever rises. Symptoms were COVID symptoms, not directly related to vaccine. The events/symptoms started on 20Dec2020. Patient had no Covid prior vaccination. The patient was COVID tested post vaccination. The patient considered the events as non-serious. The outcome of events was not recovered. Information on Lot/Batch number has been requested.
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| 47 | 2021-01-03 | pain |
short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contac...
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short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO124), via an unspecified route of administration on 23Dec2020 at 14:30 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Rheumatoid arthritis, lupus. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included baricitinib (OLUMIANT), hydroxychloroquine, prednisone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intense headache, tiredness, body aches, short of breath on 24Dec2020; events were resulted in: Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19 on 27Dec2020: Nasal Swab, result was unknown. No treatment was received for the events. The outcome of the events was not recovered.
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| 47 | 2021-01-04 | pain, pain in extremity |
12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled musc...
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12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled muscle from my neck all the way down arm. This went on for 4 days. The pain woke me up at night for 2 nights. Just took Ibuprofen. This pain has resolved. 12/29 - body aches, chills, joint pain, fatigue, SOB on exertion, runny nose, and sneezing. These symptoms went on for 5 days. Mostly resolved - still some fatigue and SOB on exertion, runny nose, and sneezing. Again, treated with ibuprofen and rest. 1/31 - Extreme nausea, aggitatation, and fatigue. Took Zofran and went to bed at 7pm and slept until 9am. Felt much better. 1/2 - Completed a virtual visit. Advised to come in to clinic for covid test only. Not seen by physician. Negative results, and no F/U from a provider. 1/5 - All symptoms resolved except some fatigue and SOB on exertion, runny nose, and sneezing.
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| 47 | 2021-01-04 | pain in extremity |
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ...
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All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-04 | dizziness |
Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light hea...
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Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.
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| 47 | 2021-01-04 | tingling, feeling hot |
At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, f...
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At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, face flushed and warm. Resolved without intervention. No other side effects except muscle soreness to this arm. ( Wouldn't report but a coworker had a similar but more severe reaction and is still having effects 3 wks out)
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| 47 | 2021-01-04 | dizziness | DIZZINESS |
| 47 | 2021-01-04 | feeling cold | Felt tired and cold Fever |
| 47 | 2021-01-04 | dizziness, weakness |
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip p...
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Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
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| 47 | 2021-01-04 | tingling |
Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. P...
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Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.
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| 47 | 2021-01-04 | numbness |
Right facial numbness; This is a spontaneous report from a contactable other healthcare professional...
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Right facial numbness; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020, 18:00 at single dose (dose 1, reported as right arm, and also reported as left arm) for COVID-19 immunization. Medical history included DM, hypothyroid, and HTN from an unspecified date. The patient's concomitant medications were not reported. No other vaccines were given in four weeks. Patient has no COVID prior vaccination and did not undergo COVID testing post vaccination. The patient has no known allergies. The patient experienced right facial numbness on 16Dec2020 19:00, also reported as 50 minutes after receiving the vaccine. She was instructed to take one dose of BENADRYL as treatment. It was reported that numbness last for about 2.5 hours. Outcome of the event was recovered on 16Dec2020. The event was reported as non-serious.
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| 47 | 2021-01-05 | pain | CHILLS , FEVER , BODY ACHES, JOINT PAIN |
| 47 | 2021-01-05 | feeling hot, tingling |
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain...
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Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
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| 47 | 2021-01-05 | weakness | Chills, fever, general weakness & fatigue, sweating |
| 47 | 2021-01-05 | dizziness |
Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minut...
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Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minutes after injection. Headache and injection site pain for 2 days after injection.
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| 47 | 2021-01-05 | tingling |
Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their le...
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Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their left arm and hand. Covid vaccine was given in left deltoid. Patient waited 30 minutes after vaccination with no new symptoms. Patient denies the need for any further medical attention. Patient left with a companion.
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| 47 | 2021-01-05 | pain |
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents w...
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Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.
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| 47 | 2021-01-05 | tingling, weakness |
Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous ...
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Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 47 | 2021-01-06 | feeling hot, dizziness | Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm |
| 47 | 2021-01-06 | pain |
Fatigue, malaise, body aches, mild headache starting 12 hours after vaccination Fever of 101.3 24 h...
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Fatigue, malaise, body aches, mild headache starting 12 hours after vaccination Fever of 101.3 24 hours after vaccination
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| 47 | 2021-01-06 | swollen extremities |
Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous repor...
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Pitting edema/Edema: It was her feet, ankles, and 3/4 way up her shins.; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: Mar2021), intramuscular in the left deltoid on 17Dec2020 at 07:15 at single dose for COVID-19 immunization. Medical history included ongoing neuralgia since 2003 (has nerve pain in her face and neck. It has never caused swelling and that she has had it for a long time. Symptoms started 17 years ago, became apparent in 2009), ongoing hypothyroidism since 2003 (Diagnosed about 17 years ago. Nothing has changed medication wise). The patient's concomitant medications were not reported. The patient reported that she got the vaccine on 17Dec2020. On 25Dec2020, her shoes felt snug and by the next day she had 4 plus pitting edema. She could not fit in the shoes. She had the pitting edema for several days. She said that she went and bought compression stockings to help with the edema. It was her feet, ankles, and 3/4 way up her shins. It was more of the pedal area that was pitting. The patient further reported that she never had pitting edema before and the only thing new she had was the vaccine. Therapeutic measures were taken as a result of the event which included compression stockings. The patient was recovering from the event.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event pitting edema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-01-06 | dizziness |
Pt received vaccine felt light headed lowered to floor 96HR 99% no respiratory distress, no allergic...
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Pt received vaccine felt light headed lowered to floor 96HR 99% no respiratory distress, no allergic rx, no loc. EMS called pt declined transport vs wnl FSBG 93 EMS left and pt lightheaded again lowered to floor MD/EMS called and pt taken to the hospital
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| 47 | 2021-01-06 | tingling |
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a...
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Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
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| 47 | 2021-01-06 | tremor | Shaking chills, myalgia and bone pain |
| 47 | 2021-01-07 | difficulty speaking |
After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER...
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After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER gave me Steroids and Pepcid. Since then I have taken Benadryl. On 12/30 at 10am I was exp reaction again went back to the ER. They provided me with breathing treatment and was sent home on Prednisone. I contacted my PCP to inform her that I have to continue taking Benadryl to help with sob and my voice changes. It seems like my lungs are affected due to taking the vaccine. I'm currently off and not able to receive comp due to the vaccine being voluntary.
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| 47 | 2021-01-07 | pain | Chills, body & joint aches, headache, fatigue, malaise |
| 47 | 2021-01-07 | dizziness | Dizziness resolved after about an hour |
| 47 | 2021-01-07 | numbness |
Numbness on the left side of the face; This is a spontaneous report from a contactable physician (pa...
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Numbness on the left side of the face; This is a spontaneous report from a contactable physician (patient). A 47-year-old non-pregnant female patient received the first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1284), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose in left arm for covid-19 immunization. Medical history included trigeminal neuralgia. Concomitant medication included colecalciferol (VITAMIN D) and multivitamin. The patient experienced numbness on the left side of the face on 22Dec2020 at 16:00, started within 2 hours of the shot and had continued for 2 weeks. The event was reported as non-serious by reporter. The patient didn't receive treatment for the event. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination, and was not tested for COVID 19 since vaccination. The outcome of the event was not resolved.
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| 47 | 2021-01-07 | dizziness | Pfizer-BioNTech COVID-19 Vaccine EUA. Sweating, lightheaded |
| 47 | 2021-01-07 | pain in extremity, tingling |
Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; modera...
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Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; moderate leg aches bilaterally; Sore arm at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm, on 30Dec2020 at a single dose for COVID-19 immunization. The patient was 47 years old when she received the vaccine. Medical history included RSD (Reflex sympathetic dystrophy), had allergies to medications, food, or other product particularly NSAID and to contrast dye. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. She had not been tested for Covid-19 since vaccination. The patient had sore arm at injection site for 36 hours after administration (02Jan2021) with outcome of recovered in Jan2021. In day #4 (03Jan2021), she had pain in hip joints and moderate leg aches bilaterally with outcome of unknown. In day #5 (04Jan2021), she had prickling needles feeling soles feet bilaterally and some in the palms of her hands with outcome of unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-01-07 | tingling | Pt report bilateral cheek tingling. Treatment include Benadryl, |
| 47 | 2021-01-07 | pain |
Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontan...
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Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
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| 47 | 2021-01-07 | pain in extremity |
Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; He...
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Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
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| 47 | 2021-01-07 | dizziness |
Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hou...
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Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hours after shot including dizziness with bending. 35 hours after dose, had dull pain on the inside prominence of my right elbow (arm I got my shot). This pain lasted for 8 hours. Also accompanied with fatigue.
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| 47 | 2021-01-07 | tingling | Throat flem, body tingles, EMS screened, increased observation time, resloved in 15 min |
| 47 | 2021-01-07 | pain |
When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm...
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When injected noted sharp shooting pain up shoulder. Site was three fingers down and also above arm pit. Site confirmed by site contact as well. Ice applied
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| 47 | 2021-01-07 | feeling hot |
Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I r...
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Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.
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| 47 | 2021-01-07 | dizziness |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | balance disorder |
excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This i...
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excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history included COVID-diagnosis from Mar2020 that resulted in blood clots and pneumonia both on 2020, and allergies to shellfish, eggs, peanuts. The patient was not pregnant. Concomitant medications included acyclovir [aciclovir], levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), escitalopram oxalate (LEXAPRO), and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020 06:00, the patient experienced extreme fatigue, temperature of 100, sore throat, loss of balance, muscle weakness, and excessive sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent other lab tests and procedures which included COVID test nasal swab was negative on 28Dec2020. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 47 | 2021-01-07 | feeling hot, tingling |
flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contact...
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flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contactable consumer (patient). A 47-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EKS730, intramuscular Left arm from 18Dec2020 16:00 to 18Dec2020 16:00 as single dose for COVID-19 immunisation. Medical history included osteoarthritis. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL). On 18Dec2020 16:30, immediately after injection, the patient experienced small amount of tingling to left hand, face warm, and flushed, which resolved within 30 minutes without intervention. The outcome of the events was recovered. No treatment was received for the events.
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| 47 | 2021-01-08 | pain |
About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke...
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About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke you with body pain everywhere, especially to arm of injection. Running fever of 101.4 and higher, all over body rash that is extremely itchy. Very fatigued feeling.
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| 47 | 2021-01-08 | dizziness, balance disorder, speech disorder |
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did...
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About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
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| 47 | 2021-01-08 | tingling |
Arms started tingling immediately after injection but did not think it was a significant response. A...
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Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
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| 47 | 2021-01-08 | pain |
Chills, low grade fever to start at 98.1, full body aches, fatigue, temperature rose to 101.1 then a...
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Chills, low grade fever to start at 98.1, full body aches, fatigue, temperature rose to 101.1 then about 9:00 pm fever broke and back down to 98.0 and felt fine ever since.
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| 47 | 2021-01-08 | dizziness | Dizziness & Angina Narrative: |
| 47 | 2021-01-08 | pain |
Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and...
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Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and throat started to swell. 50 mg of Benadryl was given. Started to feel better but 45 minutes later swelling started back up. Dryness in mouth still there and water couldn?t quench my thirst. Escorted to Emergency department. Epinephrine shot given 40mg of prednisone, 20 mg of Pepcid and 10 mg of Zyrtec given. Given another 20mg of prednisone, 10 mg of Pepcid and 10 mg of Zyrtec 1.5 hours later. Release after 4.5 hours. Given 3 days of medicine previously given. Swelling started back up 6 hours later so I took 50 mg of Benadryl. Swelling continued every 6-8 hours. Mouth was still really dry but as long as I drank 100 oz of water a day I was ok. Tuesday I had a small fever and very achy. Went to doctor and he prescribed 20 mg of prednisone twice daily tapering off for 11 days, 10 mg of Pepcid and Zyrtec twice daily for 11 more days. Finished my medicine Saturday January 2nd. I have been feeling better but still have swelling occasionally.
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| 47 | 2021-01-08 | numbness, vertigo |
She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes...
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She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes after the vaccine and lasted about 2 hours. She had no facial muscle issues. She then developed intense vertigo and nausea. I question possible vestibular neuritis. This lasted about 5 days and was more severe the first 3-4 days. At day 7 she was almost back to normal. She also had a frontal tension style headache
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| 47 | 2021-01-09 | pain |
At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection sit...
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At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.
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| 47 | 2021-01-09 | pain | Headache, body aches, malaise, chills, fever |
| 47 | 2021-01-10 | pain in extremity, pain |
01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and thro...
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01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and throbbing excruriating pain in the left arm (10/10). I was barely able to move the left arm, and I could not bend it due to severe pain in the elbow joint. At approximately 0800, I started having diarrhea that lasted for no more than an hour. By noon the soreness and aching had reduced to a moderate pain (5/10). I was able to bend my left arm, but the arm remained sore at the elbow joint until 01/10/2021. By the morning of 01/10/2021, all the symptoms were gone.
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| 47 | 2021-01-10 | pain |
72 hours of extreme fatigue. 48 hours of nausea and vomiting. 48 hours chills, aches. Ongoing headac...
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72 hours of extreme fatigue. 48 hours of nausea and vomiting. 48 hours chills, aches. Ongoing headache x5 days.
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| 47 | 2021-01-10 | feeling cold |
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to...
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? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
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| 47 | 2021-01-10 | pain |
Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirm...
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Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirmed positive
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| 47 | 2021-01-10 | pain |
Five hours after vaccination developed Left scapula pain, chills, headache, body ache , general mala...
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Five hours after vaccination developed Left scapula pain, chills, headache, body ache , general malaise end left axillary pain
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| 47 | 2021-01-10 | pain in extremity, weakness |
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccina...
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I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
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| 47 | 2021-01-10 | pain |
Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to s...
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Metallic taste in mouth for 5 to six minutes after injection. Body aches 4 hours later, able to sleep after 2 Aleve.
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| 47 | 2021-01-10 | pain | Mucular pain Achy Joint pain Headache Injection site pain that radiated whole right arm |
| 47 | 2021-01-10 | seizure |
Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her head...
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Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.
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| 47 | 2021-01-10 | tingling, weakness, tremor, restlessness, pain in extremity, feeling hot |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | nerve pain, pain, facial paralysis |
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume...
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ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
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| 47 | 2021-01-10 | numbness, tingling |
c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips -...
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c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips - per physicians consideration: patient should continue to watch or any signs of swelling, redness, and/or soreness. Tingling/numbness possibly due to hitting a nerve.
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| 47 | 2021-01-10 | pain | fatigue body aches chills fever headache |
| 47 | 2021-01-10 | pain | fatigue,nausea, body aches, head ache, chills |
| 47 | 2021-01-10 | pain | headache, body aches, fever |
| 47 | 2021-01-10 | one side paralysis, pain, weakness |
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o...
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vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
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| 47 | 2021-01-11 | dizziness |
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes...
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Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-11 | weakness | Arm pain and weakness for 10 (ten) days. 600 and 800 mg doses of ibuprofen |
| 47 | 2021-01-11 | pain |
Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after bei...
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Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after being vaccinated and continued to get worse over a period of 6 hours. Nausea and stomach pain also present. Diarrhea started 19 hours after being vaccinated. Body aches and diarrhea continued for a total of around 20 hours of symptoms.
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| 47 | 2021-01-11 | tenderness |
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of...
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Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
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| 47 | 2021-01-11 | pain in extremity | Headache, Sore Arm |
| 47 | 2021-01-11 | pain | Nausea, Chills, Body Aches |
| 47 | 2021-01-11 | pain in extremity, pain |
Pain in arm to the point patient states they are unable to lift the arm. Patient instructed to foll...
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Pain in arm to the point patient states they are unable to lift the arm. Patient instructed to follow up with PCP to have arm visualized and treated if necessary.
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| 47 | 2021-01-11 | pain, weakness |
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later...
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Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
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| 47 | 2021-01-11 | numbness, feeling cold |
Pt states cool sensation to right side of face and numbness to right hand- EMS evaluated and some re...
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Pt states cool sensation to right side of face and numbness to right hand- EMS evaluated and some resolution of cool sensation to face, hand remains numb
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| 47 | 2021-01-11 | pain in extremity |
Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (l...
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Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (like a sunburn) at 2pm. Also felt jittery. Spoke to ER physician and advised to take po Benadryl. Took 2 doses before redness cleared. Jitteriness cleared the next day without Benadryl.
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| 47 | 2021-01-11 | pain, pain in extremity |
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 ...
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Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
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| 47 | 2021-01-11 | pain in extremity, pain |
Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued t...
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Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued to get better of the course of 3 days. No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
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| 47 | 2021-01-11 | dizziness, pain |
body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec20...
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body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec2020; second dose 05Jan2021; dizziness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in the right arm on 05Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included heart attack three years ago which predates treatment with the Pfizer COVID 19 vaccine. The patient's concomitant medications were not reported. The patient previous received the first dose of the Pfizer COVID 19 vaccine (first dose lot= EH9899) on 17Dec2020 at 17:30 PM in the right arm and reported no reactions to the vaccine. The patient experienced dizziness on 05Jan2021, body aches/aches all over her body like a fever, nausea on 06Jan2021. Consumer calling regarding the Pfizer COVID 19 vaccine. States she never had side effects with the first shot but the second was killing her. Clarified she received the first dose of the Pfizer COVID 19 vaccine 17Dec2020 at 17:30 PM in the right arm. She didn't have any effects after that dose. Reports she received the second dose of the Pfizer COVID 19 vaccine 05Jan2021 at 17:30 PM in the right arm. She noticed about 20 minutes after the injection on the way home, she felt dizzy had to pull over. The next morning, she continued to experience a little dizziness with nausea but states she never threw up and she had aches all over her whole body, like a really bad fever but she didn't have a fever. She was still feeling the body aches but when she gets up and walks it gets worse, like if she went to work so she stayed home today and she can still feel it a little but it is less since she is relaxing. From her vaccine card she provides the lot number for the first dose and the lot number for the second dose EK9231; does not see NDC or expiration date. The outcome of events for dizziness, nausea was resolved on 06Jan2021, for body aches/aches all over her body like a fever was not resolved. The adverse event didn't require a visit to physician office nor emergency room. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to adverse event was none. Relevant tests were none. Vaccination Facility Type: Hospital. Vaccine Administered at Facility: No.
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| 47 | 2021-01-11 | weakness |
patient developed occipital headache, backache, flushed sensation, and weakness; has known history o...
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patient developed occipital headache, backache, flushed sensation, and weakness; has known history of "MS". pt. given a water, vitals signs taken, and 1st response team called to transport to ED.
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| 47 | 2021-01-11 | pain |
she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle j...
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she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle joint pain; exhausted with a headache/ She doesn't want to get up she is tired; exhausted with a headache/slight headache; muscle joint pain which is a stabbing pain all over her body; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, manufacturer: Pfizer), via an unspecified route of administration on 04Jan2021 14:00 at single dose for Covid-19 immunization. Medical history included ongoing childhood asthma, COVID 19 positive from 07Dec2020 to an unknown date. There were no concomitant medications. The patient felt like she had covid symptoms, chills, low grade fever, muscle joint pain, exhausted with a headache/ she doesn't want to get up she was tired, muscle joint pain, which was a stabbing pain all over her body, feeling unwell, all on 05Jan2021 05:00. The events were reported as non-serious. Caller had Sars-COV-2 infection diagnosed 07Dec2020. Received first dose of vaccine 04Jan2021 at 14:00. She was experiencing chills, low grade fever, muscle joint pain, exhausted with a headache. Asking for information on efficacy of second dose. She didn't have any side effects or anything initially. Then, 12 hours later at 5- 6 am she felt like she had COVID symptoms. She already had COVID so she known what it feels like. She was wondering how long would last. It was almost like having real COVID. She didn't have a prescribing doctor. She had COVID 07Dec2020. She was currently experiencing Chills, fever low grade, muscle joint pain which was a stabbing pain all over her body, and she was feeling unwell. She didn't want to get up she was tired. She has a slight headache. This all started at 5 am on 05Jan2021. Even with medication. She has been taking paracetamol (TYLENOL) and excedrin. She cannot work if she wanted to, but these effects are not serious. Her fever has went down. The chills have stayed the same. She was diagnosed with childhood asthma. Caller asked about interval information between the SARS-COV-2 infection diagnosed 07Dec2020 and her first dose of vaccine 04Jan2021 at 14:00. The outcome of events for felt like she had covid symptoms was unknown, for low grade fever was resolving, for other events was not resolved.; Sender's Comments: There is not a reasonable possibility that event suspected COVID-19 is related to BNT162B2. There is no test done to confirm whether patient got COVID-19 or not. And symptoms that were suspected by reporter as due to COVID-19 occurred one after the vaccination, when vaccine was not expected to achieve the effect.
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| 47 | 2021-01-11 | pain in extremity |
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a...
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tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
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| 47 | 2021-01-11 | dizziness, numbness |
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f...
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tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-12 | feeling hot, dizziness |
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79...
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1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better. 1409: 70 HR, 115/76, 100%, orthostatics taken. 1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
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| 47 | 2021-01-12 | pain | Chills, headache and body ache that started approx 12 hours after vaccine admin |
| 47 | 2021-01-12 | pain, pain in extremity | Chills, headache, arm pain, nausea, body aches and pain |
| 47 | 2021-01-12 | tingling | Light fluttery, tingles throughout bilateral arms down through hands- |
| 47 | 2021-01-12 | feeling hot |
Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart ra...
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Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart rate 100. 8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose. 8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
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| 47 | 2021-01-12 | tenderness |
Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my ...
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Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my neck also on 1/12/2021 I had the second shot on 1/11/2021 at 12pm"
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| 47 | 2021-01-12 | feeling hot |
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving...
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Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
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| 47 | 2021-01-12 | pain in extremity |
Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and tod...
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Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and today. Major headache today, not all day just part of day.
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| 47 | 2021-01-12 | tingling |
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down...
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approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
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| 47 | 2021-01-12 | feeling hot, lightheadedness, weakness |
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ...
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feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
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| 47 | 2021-01-13 | pain |
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and...
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12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
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| 47 | 2021-01-13 | dizziness, migraine |
Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, mus...
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Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, muscle ache 1/9/21 through 1/14/21. Severe headache/migraine from 1/11/21 to present (still have).
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| 47 | 2021-01-13 | pain | Patient describes fever, chills, bone pain and body ache |
| 47 | 2021-01-13 | dizziness |
Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathi...
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Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathing/shortness of breath but pt states it may be associated with the mask.
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| 47 | 2021-01-13 | pain |
Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the...
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Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
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| 47 | 2021-01-13 | numbness |
Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after takin...
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Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after taking benadryl and is back to normal-Severe; symptoms lasted 0 days
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| 47 | 2021-01-13 | dizziness | Systemic: Lightheadness for 30 mins felt better after resting-Medium; symptoms lasted 0 days |
| 47 | 2021-01-13 | dizziness |
Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; sy...
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Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; symptoms lasted 1 day
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| 47 | 2021-01-13 | feeling hot |
Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms las...
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Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms lasted 1 day
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| 47 | 2021-01-13 | pain |
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE...
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THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
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| 47 | 2021-01-13 | pain in extremity |
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a...
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a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
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| 47 | 2021-01-13 | pain in extremity |
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of...
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intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
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| 47 | 2021-01-14 | numbness |
24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No S...
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24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No SOB, no swelling. 4 days later lips tingling. 7-9 days later random numbness and tingling of tongue, r. cheek, lips....comes and goes. No rescue medication used. No follow up pursued by patient.
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| 47 | 2021-01-14 | dizziness |
Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old fema...
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Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 (Batch/lot number: EJ1685) at a single dose on left arm, and received the second dose, intramuscular on 08Jan2021 (Batch/lot number: EK9231) at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded and flushed on an unspecified date. Treatment not received for the adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 47 | 2021-01-14 | dizziness |
Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. ...
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Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. Symptoms passed after 10 minutes of observation. Sent patient home per her request.
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| 47 | 2021-01-14 | pain in extremity, pain, tenderness |
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f...
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The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
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| 47 | 2021-01-14 | inability to speak, slurring, balance disorder |
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t...
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approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
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| 47 | 2021-01-14 | feeling hot | felt body rush, got hot rise from legs on up |
| 47 | 2021-01-15 | pain, dizziness |
1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near sync...
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1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near syncope episode with severe dizziness, nausea, tachycardia, high blood pressure. Benadryl 50 mg was administered. 45 minutes after Benadryl administration driven home and severe dizziness was present until next morning. 17 hrs post injection had severe flu like symptoms (chills, severe headache, muscle/body aches/no fever). Took Advil 800mg. At 48hrs no symptoms remain. At 69 hrs post injection had severe dizziness that is still present at 72.5 hrs post injection.
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| 47 | 2021-01-15 | pain |
Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not...
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Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not responsive to Tylenol or ibuprofen. On day two fever that got as high as 101 degrees was observed. Severe headaches lasted from 4 hours after second injection until 48 hours after second injection. Beginning at about 48 hours post second injection painful tender lymphadenopathy observed in axillary area of left arm. I am now 96 hours post second injection and the lymph nodes in that left arm are still swollen and tender and painful.
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| 47 | 2021-01-15 | tingling, dizziness, numbness |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-15 | tingling |
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor...
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Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
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| 47 | 2021-01-15 | tingling, dizziness |
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin...
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Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
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| 47 | 2021-01-16 | pain in extremity, pain |
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle...
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Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
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| 47 | 2021-01-16 | pain |
Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left ...
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Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left shoulder. Most symptoms lasted 36 hrs, nausea and fatuge lasted 48 hrs
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| 47 | 2021-01-16 | feeling hot |
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m...
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I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
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| 47 | 2021-01-16 | pain in extremity |
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d...
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severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
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| 47 | 2021-01-17 | dizziness, weakness, tremor, feeling cold |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-18 | weakness, dizziness | Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever |
| 47 | 2021-01-19 | dizziness | Bad headache, stomach cramps, nausea, dizziness for 24 hours |
| 47 | 2021-01-19 | lethargy, pain | Chills, lethargy, body aches |
| 47 | 2021-01-19 | pain, weakness | Fever of 103, severe chills, body aches, joint pain, weakness, cough, headache, sore throat |
| 47 | 2021-01-19 | dizziness |
I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt...
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I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt lightheaded and like I was going to pass out. After a bit I felt a little better but remained dizzy and lightheaded. On the 7th I continued to feel dizzy and lightheaded throughout the day. I was sitting down on a call in the afternoon when my Apple watch vibrated and indicated my heart rate was below 50 for 10 minutes. I checked my heart rate and it was 38 - 48 BPM. On the morning of the 8th I reported my persistent symptoms to Dr. and an EKG was done showing a heart block. I have had bradycardia for the past year and likely the heart block but was not symptomatic until after I took the vaccine. See next pg
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| 47 | 2021-01-19 | weakness |
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra...
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Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
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| 47 | 2021-01-19 | pain |
Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, un...
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Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, unrelieved with OTC intervention. Continued for 34 hours. Temp continued thru 12/27/20. Aching, severe fatigue. Diarrhea stopped after 34 hours. Has been intermittent nearly daily since. Only occasional 24 hour periods without it. When diarrhea resumed following the 34 hour stretch, MD prescribed Lomotil. Lomotil was taken x4 days, then diarrhea stopped x2 days, then resumed again. Diarrhea continues at this time along with pain in upper stomach area, intermittent lower abdominal cramps that occur prior to episodes. Remains unable to eat normal foods r/t stomach pain and diarrhea
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| 47 | 2021-01-19 | tremor |
Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt h...
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Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt her legs shaking and tingling on her top lip. She came back to the vaccine clinic and asked to be monitored. Vital signs taken 138/90, HR 109 POX 100 RA. Continued to have tingling upper lip and brought to ED for further observation. Warm hand off to ED RN
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| 47 | 2021-01-19 | tenderness |
Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my va...
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Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my vaccine was sore to the touch. As the evening progressed, my shoulder joint became sore and got worse throughout the evening and became very sore to lift my arm. This morning it is still very sore, and now my neck feels ?stiff? and also it?s tender to move.
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| 47 | 2021-01-19 | pain in extremity, pain |
Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in...
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Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in ER after 24 hours of symptoms. Fatigue for 1 week post vaccination.
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| 47 | 2021-01-19 | pain |
Started having body aches at 1800 the day of administration. Continues to have mild headache and bo...
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Started having body aches at 1800 the day of administration. Continues to have mild headache and body aches.
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| 47 | 2021-01-19 | weakness, pain |
Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with...
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Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with fever and chills until 7pm. Had a throbbing headache from 2pm until midnight. Severe muscle weakness and bone pain. No appetite at all. Next day still weak and sore but fever gone and about 75% better.
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| 47 | 2021-01-19 | pain |
fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am ...
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fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am along with headache and constant watery eyes. Difficulty taking deep breaths due to muscle soreness in back and ribs
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| 47 | 2021-01-19 | pain |
pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours o...
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pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours of vaccine, treated with otc naproxen 220 mg q12 hours prn pain continued next day, continued otc naproxen 220 mg 2 12 hours
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| 47 | 2021-01-19 | dizziness |
pt c/o dizziness 15-20 after vaccine. B/P 154/104 HR63 O2 sat 100%. states no history of hyperten...
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pt c/o dizziness 15-20 after vaccine. B/P 154/104 HR63 O2 sat 100%. states no history of hypertension. C/o having a busy day at work. B/P recheck 3 mins later 154/85. Vaccine given at 454pm. Pt not feeling better at 6:40pm. Sent pt to ER. Still with dizziness. Able to walk but unable to drive per pt. Gave juice and cookies to pt starting at 5:15pm. did not improve her status
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| 47 | 2021-01-21 | pain | CHILLS, BODY ACHES |
| 47 | 2021-01-21 | pain | DOLOR EN AMBOS AXILAS Y EL CUERPO. PRESENTA HEMATOMAS EN AREA DE AXILAS EN AMBOS BRAZOS. |
| 47 | 2021-01-21 | pain | Fever, chills, nausea, vomited, body aches, |
| 47 | 2021-01-21 | migraine, pain |
Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull o...
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Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull on the same side where I got the shot in my left shoulder
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| 47 | 2021-01-21 | migraine, pain |
Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on th...
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Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on the same sideI received the shot in my shoulder
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| 47 | 2021-01-24 | dizziness |
2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upp...
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2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upper back and neck; 1700 achiness in upper back and neck; 1200 extreme fatigue/tiredness became more pronounced; On day of 2nd shot:1100 dizziness and slight headache; On day of 2nd shot:1100 dizziness and slight headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 47-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot # EL3246, via an unspecified route of administration on 12Jan2021 at 08:30, at 47-years of age, at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Lot # EL0140) in left arm on 22Dec2020 at 08:30 am; medical history included food allergy including fish, shellfish, seafood of all types and corn, gastrooesophageal reflux disease, an unspecified neoplasm malignant, Vertical Sleeve gastrectomy (VSG) and neuropathy peripheral, all from an unknown date. Concomitant medication included amlodipine, pantoprazole, cetirizine hydrochloride (ZYRTEC), zinc and magnesium. The patient was vaccinated in Hospital and she was not pregnant when she received the vaccine. On 12Jan2021, day of 2nd vaccine shot, at 11:00 the patient experienced dizziness and slight headache, at 12:00 she experienced extreme fatigue, at 17:00 she suffered from achiness in upper back and neck, at 20:30 her arm became quite sore; on 13Jan2021 all symptoms continued and tiredness became more pronounced and, on 14Jan2021, the only remaining symptoms were slight soreness at injection site and some achiness in upper back. All other symptoms had resolved. No treatment was received for the reported events. The patient has not been tested for COVID-19 after vaccination. At the time of the report the events dizziness, slight headache, extreme fatigue/tiredness became more pronounced had resolved and the events soreness at injection site and achiness in upper back were recovering.
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| 47 | 2021-01-24 | dizziness | Dizziness and Chest pain-- > ER |
| 47 | 2021-01-24 | pain in extremity |
Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontane...
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Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 47 | 2021-01-24 | dizziness |
On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On ...
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On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On 01/23/2021, experienced same symptoms plus dizziness and muscle aches. Vomiting subsided on 01/24/2021 at 3:00pm. Muscle aches subsided on 01/25/2021 at 10:00am. Other symptoms persist. Nausea, fatigue, and dizziness are severe.
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| 47 | 2021-01-25 | pain |
High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot...
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High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 47 | 2021-01-25 | pain in extremity |
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was ab...
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Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
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| 47 | 2021-01-25 | tremor | Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg |
| 47 | 2021-01-25 | pain, migraine |
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa...
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Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
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| 47 | 2021-01-25 | pain in extremity |
This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient receiv...
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This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on30Dec2020 to 30Dec2020 at single dose for COVID-19 immunization. She had a history of pancreatitis and was hospitalized with elevated lipase levels one and a half weeks prior to getting her first dose in Dec2020. When she received the first dose she had recovered and her lipase levels were normal in Dec2020. Her gastroenterologist has scheduled her for a colonoscopy and upper endoscopy but would like for her second dose to be spaced out a week from her first dose. She is asking if there is any data to support efficacy of the second dose of the vaccine between days 28-32. The doctor stated she is okay as long as she gets the second dose of the vaccine within 5 months from the first dose. She had pancreatitis and needs to have a procedure for it. She was scheduled for second dose on 18Jan2021. She has an endoscopy and colonoscopy scheduled for 21Jan2021 and her GI doctor advised to postpone her second dose which she was told she should get 17- 21 days after her first dose since it would coincide with her procedure. She does not have a problem with the vaccine. She had a sore arm on an unknown date and was totally fine. The outcome of the event sore arm was recovered on an unknown date. Information on the lot/batch number has been requested.
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| 47 | 2021-01-25 | pain |
severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a...
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severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a contactable nurse (patient). A 47-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL3249), via an unspecified route of administration on 09Jan2021 11:15 at single dose at right arm for covid-19 immunization. Medical history included mild asthma, known allergies: latex, peanuts from an unknown date and unknown if ongoing, and the patient was diagnosed with COVID-19 prior to vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EH9899) at single dose at right arm on 19Dec2020 11:15 am for covid-19 immunization. About 12 hours after the vaccination patient had severe body aches, joint pain, chills, headache, nausea, diarrhea on 09Jan2021 09:00 PM. All symptoms lasted from 12-16 hours, except the diarrhea lasted about 20 hours. Outcome of all events was recovered on 10Jan2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
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| 47 | 2021-01-26 | pain | chills and fever of 101.4, body aches, sore arm at injection site |
| 47 | 2021-01-28 | bell's palsy | Bell Palsy |
| 47 | 2021-01-28 | feeling hot |
Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision;...
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Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.
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| 47 | 2021-01-28 | dizziness | DIZZINESS |
| 47 | 2021-01-28 | feeling hot, feeling cold |
ears have been burning; she checked her temperature and it is lower than normal, her temperature is ...
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ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
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| 47 | 2021-01-28 | weakness, dizziness |
she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so ...
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she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 47 | 2021-01-31 | tingling |
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ...
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my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-01 | tingling |
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from...
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throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-03 | feeling of body temperature change | NauseaVomiting "Hot and cold, afebrile" Narrative: |
| 47 | 2021-02-03 | tingling, dizziness, numbness, weakness |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-06 | numbness, pain in extremity, weakness, dizziness |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-10 | pain, pain in extremity |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-14 | dizziness |
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours...
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syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-21 | dizziness |
48 hours after the second dose of Pfizer COVID19 vaccine I started feeling very dizzy. I also felt v...
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48 hours after the second dose of Pfizer COVID19 vaccine I started feeling very dizzy. I also felt very tired and sleepy, kind of getting a cold, with weird head ache. I almost never have head aches. I also experienced chills. Oddly, my husband got all the same symptoms very same day, as if I had 'infected' him with the vaccine. The feeling sick symptoms passed in about 2-3 days, but the weird stuffiness and some sort of pressure in my brain has stayed, and is annoying. I have not had this kind of head sensation before, and it is not going away. I have since had 2 negative covid RT-PCR tests.
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| 47 | 2021-02-21 | numbness |
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron...
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About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
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| 47 | 2021-02-21 | dizziness |
Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache an...
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Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days
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| 47 | 2021-02-21 | pain |
Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest p...
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Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest pain that radiates into shoulders.
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| 47 | 2021-02-21 | pain in extremity |
sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-fema...
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sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Jan2021 16:15 (lot number: el3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient's concomitant medication included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC). The patient did not receive other vaccines within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm x2 days on 21Jan2021 at 07:00 AM. The patient did not received treatment. The consumer assessed the event as non-serious. The outcome of the event was recovered in 23Jan2021. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-22 | dizziness | Dizziness |
| 47 | 2021-02-22 | swollen extremities | Swelling underneath arm pit. doctor advised Tylenol and warm compress |
| 47 | 2021-02-23 | pain in extremity |
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli...
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Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
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| 47 | 2021-02-25 | migraine |
sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit,...
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sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
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| 47 | 2021-03-02 | numbness, tingling |
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to ...
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numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.
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| 47 | 2021-03-04 | weakness, dizziness |
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; s...
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Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 47 | 2021-03-09 | pain |
Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, over...
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Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, overnight in hospital with body aches, headache, had third episode in the morning 24 hrs after injection
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| 47 | 2021-03-14 | weakness, unresponsive to stimuli, pain |
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh...
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PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
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| 47 | 2021-03-15 | dizziness |
Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish...
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Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
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| 47 | 2021-03-18 | pain in extremity, pain |
Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain ...
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Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until the morning of March 5th . Was diagnosed with a very large blood clot in lower leg going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
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| 48 | 2020-12-31 | feeling hot, slurring, weakness, pain in extremity |
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the...
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After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
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| 48 | 2020-12-31 | pain in extremity |
Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade te...
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Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade temperature for 3 day..left arm still very sore on day 4
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| 48 | 2020-12-31 | dizziness |
Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced s...
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Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.
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| 48 | 2021-01-01 | pain | Fever, chills, body aches for one day. Took only Tylenol 650mg 6 hrly. |
| 48 | 2021-01-01 | pain, numbness |
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ...
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Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
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| 48 | 2021-01-03 | tingling, swollen extremities |
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas...
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26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | pain |
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Gen...
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Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
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| 48 | 2021-01-03 | pain in extremity |
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula...
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Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
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| 48 | 2021-01-03 | vertigo, pain in extremity, dizziness |
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, craw...
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dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | tingling |
employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flush...
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employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up
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| 48 | 2021-01-04 | swollen extremities |
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin...
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Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
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| 48 | 2021-01-04 | pain |
Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from ...
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Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.
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| 48 | 2021-01-04 | pain, tremor, weakness |
I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still fee...
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I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, "I can't even read, it says EK or E something 5730. That's what it looks like."), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, "I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?" Consumer stated, "Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas." When probed if calling for the first time in Pfizer drug safety department, consumer stated, "No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit." .Height and weight: Consumer stated, "I say about 130 and about 5'6.". LOT#: Consumer stated, "Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like."Manufacturer name: Consumer stated, "Covid 19 Vaccine and I'm pretty sure it's Pfizer.".Lab work: Consumer stated, "I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done.".Date of administration of first dose: Consumer stated, "It was probably like December 8th. I had it done on 23rd of December." (Not further clarified).Event date: Consumer stated, "The same day I had the shot.".When probed if still experiencing the events, Consumer stated, "Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy." .Treatment: Consumer stated, "Tylenol and Ibuprofen I keep alternating it."Consumer stated, "I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got." .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-01-04 | pain |
I have preexisting chronic neck pain that prior to the vaccine rated 0-2 on a daily basis. A MRI wa...
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I have preexisting chronic neck pain that prior to the vaccine rated 0-2 on a daily basis. A MRI was obtained in approx 2015 that showed encroachment in the cervical spine. Since the day after the 1 dose the pain daily has rated from 2-5 and has been persistent.
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| 48 | 2021-01-04 | pain |
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity...
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I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
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| 48 | 2021-01-04 | dizziness |
Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. ...
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Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. Patient was asked if she had any adverse reactions to vaccine or products containing polyethylene glycol ( bowel preps/ cosmetics/ lotions). Patient denied any allergies except to Penicillin. Patient consented to receive vaccine. Pfizer Covid vaccine administered at 9:21 am. No immediate reaction. Patient denied any pain at injection site. Patient escorted to observation area. At 9:30 am the patient complained of nausea and proceeded with dry heaves. Patient did state she had eaten in the morning. Patient with good radial pulses at rate of 88. Patient then stated she felt dizzy and patient was assisted to the floor and placed in a recovery position. The patient DID NOT have change in mental status or decrease in mental status. Initial BP 162/102 - HR 88. Patient continued with nausea, dry heaves and dizziness. 911 was called. Patient maintained a BP of 160-172 systolic and pulse rate of 120, RR 40. Patient WITHOUT rash, swelling, wheezing, SOB or change in LOC. Benadryl was administered at 0945. Medics arrived at 9:47. Patient was transported to local hospital. No change in patient status upon departure. Patient remained nauseated, with dry heaves and dizziness.
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| 48 | 2021-01-04 | pain in extremity, dizziness |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-04 | pain in extremity | Sore Arm for 24 hours. Advil |
| 48 | 2021-01-04 | pain |
Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes...
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Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself). This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
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| 48 | 2021-01-04 | pain in extremity |
This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spon...
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This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spontaneous report from contactable Nurse reporting for herself via Pfizer Sales Representative. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #EJ1685), intramuscular into the right arm on 29Dec2020 11:15 at 0.6 mL, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The administer cleaned the arm with alcohol but didn't wait for it to dry. On 29Dec2020 the patient experienced immediate pain in the arm. The pain has continued for the past 20 hours. The outcome was recovered.
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| 48 | 2021-01-04 | tingling, balance disorder, numbness |
had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left s...
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had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
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| 48 | 2021-01-04 | pain in extremity, numbness | numbness left side of body including face, arm, leg pain left side of body in several places |
| 48 | 2021-01-04 | numbness, pain |
numbness on left side of body including face, arm and leg Pain on left side in various places Starte...
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numbness on left side of body including face, arm and leg Pain on left side in various places Started soon after vaccine
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| 48 | 2021-01-04 | pain, numbness |
numbness on left side of face, left arm and pain in different places on left side started for shortl...
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numbness on left side of face, left arm and pain in different places on left side started for shortly after vaccine. She has had all these symptoms prior but numbness never this bad. As of today, her symptoms are somewhat less. She has been able to work
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| 48 | 2021-01-05 | lethargy |
12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albutero...
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12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albuterol MDI utilized and symptoms subsided. 3:30pm Mild Headache and back pain. Fatigue and lethargic. Pain scale 3-4 5:15pm Headache increased intensity. Fatigue and lethargic. Back pain still the same, took Motrin 600mg-OTC Wheezing, used Albuterol-MDI 7:30pm Headache and back pain increased intensity 12/23/2020 4:54am Woke up with wheezing, headache and back pain. Pain scale 6 Albuterol-MDI utilized 7:42am Wheezing and SOB, Albuterol utilized and symptoms subsided 3:00pm Headache increased intensity throughout the day. Difficulty focusing and multitasking. Loosing train of thought. Fatigue and lethargic. Pain scale7. Motrin OTC 800mg taken with evening medications and went to sleep. 12/24/2020 7:23am Woke up with severe headache and anosmia. 12/25/2020 Headache and anosmia 12/26/2020 Headache and anosmia 12/27/2020 COVID test-Negative result Headache and anosmia 12/28/2020 Headache and anosmia 12/29/2020 Headache and anosmia. Doctor's appointment. Headache treated with Tramadol 12/30/2020 Headache and anosmia. Pain scale 6 12/31/2020 Headache and anosmia Pain scale 3-4 01/01/2020 Headache and anosmia Pain scale 2-3 01/02/2020Headache and anosmia Pain scale 0-2 01/03/2020 Headache and anosmia Pain scale 0-1 01/04/2020 Anosmia 01/05/2020 Headache and anosmia Pain scale 2-3 01/06/2020 Headache and anosmia Pain scale 3-4
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| 48 | 2021-01-05 | numbness, tingling |
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness ...
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After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.
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| 48 | 2021-01-05 | swollen extremities, pain in extremity |
Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual wor...
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Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis
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| 48 | 2021-01-05 | pain |
Arm pain at injection site; general body aches; This is a spontaneous report from a contactable cons...
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Arm pain at injection site; general body aches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot: EK 5930, intramuscularly on 30Dec2020 11:30 (at the age of 48-years-old), as a single dose in the left arm for COVID-19 immunization. Medical history included penicillin and cephalosporins allergy, possible Behcet's Syndrome, allergies and COVID-19 (diagnosed prior to the vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported; however, it was reported that the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took codeine and experienced allergies. On 30Dec2020 at 20:00 on the second day (as reported), the patient experienced arm pain at the injection site and general body aches. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the arm pain at the injection site and general body aches was resolving.
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| 48 | 2021-01-05 | dizziness |
At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I exper...
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At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I experienced hearing loss in my left ear like I had an ear infection. This morning I woke up and it is worse. I can barely hear out of my ear and I have tinnitus. I am dizzy and feel cautious.
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| 48 | 2021-01-05 | pain |
Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two inject...
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Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two injections given to her-Toradol, Zofran, Iv therapy also, prescription for Urrelvy-for migraines-she didn't fill it yet
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| 48 | 2021-01-05 | dizziness, numbness, tingling |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | pain | Chills, shivering , body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | pain, pain | Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | dizziness |
Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like ...
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Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like I got a servere flu
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| 48 | 2021-01-05 | tingling, dizziness |
Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for ...
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Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for 30 minutes.
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| 48 | 2021-01-05 | numbness |
Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild h...
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Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild headache, numbness in both hands but more significant in the left hand, left foot numbness.
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| 48 | 2021-01-05 | dizziness |
Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable...
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Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable to walk properly), dizziness, severe nausea. 5th day- nausea, headache, muscle aches. No fever. 6th day(today) not getting better, still very nauseous, severe headache, dizziness, stomach is upset. Symptoms dont seem to be getting better.
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| 48 | 2021-01-05 | pain, weakness |
Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested posi...
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Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.
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| 48 | 2021-01-05 | tingling |
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit...
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chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
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| 48 | 2021-01-05 | pain |
fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache...
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fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache, fatigue, face feeling flush for 48hours beginning approximately 3 hours post second vaccination treated with acetaminophen, ibuprofen, fluids and rest
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| 48 | 2021-01-05 | tingling |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-05 | feeling hot |
patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. ...
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patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. Patient taken to ER and was given PO Benadryl 50mg and observed. Discharged 2 hrs later
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| 48 | 2021-01-05 | vertigo |
severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous ...
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severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'. The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.
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| 48 | 2021-01-05 | pain in extremity |
they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis s...
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they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history included Meniere's disease (reported 'Meniere's disease in my left ear'). The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 48 | 2021-01-06 | tingling, weakness, tremor |
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a...
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On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
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| 48 | 2021-01-06 | tremor |
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking...
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Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
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| 48 | 2021-01-06 | dizziness |
Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/heada...
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Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness
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| 48 | 2021-01-06 | pain in extremity |
Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous ...
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Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-01-06 | pain in extremity |
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chill...
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Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue
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| 48 | 2021-01-06 | numbness |
left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneousl...
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left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously
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| 48 | 2021-01-06 | numbness |
numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash...
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numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash noted, Initially refused Benadryl po instead requested to stay for observation for an additional 15minutes. Symptoms persisted, denies shortness of breath, ithcing, denies swelling of tongue, At 1500 Benadryl 25mg given po, patient stayed for observation for 15 minutes and was ready to leave at that time.
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| 48 | 2021-01-07 | pain |
3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke...
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3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke up feeling better. Went to bed early and feel fine.
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| 48 | 2021-01-07 | weakness | Chills, generalized weakness, fatigue |
| 48 | 2021-01-07 | tingling, pain |
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav...
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I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
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| 48 | 2021-01-07 | weakness, pain in extremity, pain |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-07 | dizziness | Metal taste in mouth after receiving the vaccine, headache, fatigue, Fever for 12 hours, dizziness |
| 48 | 2021-01-07 | pain in extremity | Patient describes sore arm, |
| 48 | 2021-01-07 | pain |
Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuf...
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Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache, feeling "foggy".
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| 48 | 2021-01-07 | tenderness, dizziness, pain in extremity |
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala...
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Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
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| 48 | 2021-01-07 | migraine |
Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved b...
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Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved but with occasional palpitations.
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| 48 | 2021-01-07 | seizure |
The patient reported shortness of breast and difficulty breathing. The patient's husband stated tha...
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The patient reported shortness of breast and difficulty breathing. The patient's husband stated that he witnessed the patient having a seizure. Patient advised to call EMS. EMS took the patient to hospital. The patient was stabilized after receiving emergency treatment.
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| 48 | 2021-01-07 | migraine, pain, dizziness, feeling cold |
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going...
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about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
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| 48 | 2021-01-07 | dizziness |
diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair t...
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diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
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| 48 | 2021-01-07 | dizziness, lethargy | headache, muscle aches, chest tightness, lethargic, lightheaded for three days. |
| 48 | 2021-01-08 | feeling cold |
Employee Health notified several days after first vaccination that she had a sore throat, felt cold,...
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Employee Health notified several days after first vaccination that she had a sore throat, felt cold, "brief asthma attack" one hour after being vaccinated. Did not seek medical care. Inhaler used and symptoms went away 15-20 minutes later.
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| 48 | 2021-01-08 | tingling |
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i...
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Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
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| 48 | 2021-01-08 | pain | Fever (101.4), Body Aches, Headache Treatment - Acetaminophen |
| 48 | 2021-01-08 | vertigo, dizziness |
Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Wen...
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Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Went to open MD who recommended epley maneuver . Was told to do this for "several days" and then come back if it did not go away. Maneuver was done for three days before vertigo went away, but constant dizziness for another three days, and then intermittent dizziness still ongoing. Called into work.
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| 48 | 2021-01-08 | feeling cold, feeling hot, tremor |
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " ...
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Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference" Tearful, skin felt clammy.
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| 48 | 2021-01-08 | pain | fever chills body aches, massive headache and nausea |
| 48 | 2021-01-08 | pain in extremity | fever, chills, arm pain, muscle aches, severe headache, |
| 48 | 2021-01-09 | pain |
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm l...
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1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
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| 48 | 2021-01-09 | pain in extremity |
Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp th...
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Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp that peaked 101, aches and chills. Symptoms lasted about 15 hours. Upon waking on 1/10/2021 no fever, aches or chills. Sore arm continues.
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| 48 | 2021-01-09 | tingling |
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea...
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Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
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| 48 | 2021-01-09 | pain in extremity, pain |
Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. T...
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Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.
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| 48 | 2021-01-10 | feeling hot, pain, nerve pain |
6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin...
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6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin daily. s/s today left shoulder nerve pain (had injection on right side) 6/10. No body ache, diarrhea, chills today. COVID 1/8 test negative.
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| 48 | 2021-01-10 | dizziness, unresponsive to stimuli |
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an...
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After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
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| 48 | 2021-01-10 | pain | Body ache, headache and nausea. |
| 48 | 2021-01-10 | pain | Chills, sweats, body aches, headache joint pain |
| 48 | 2021-01-10 | pain | Fever 100.8 and sever aches. |
| 48 | 2021-01-10 | numbness |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | pain | Low grade fever 100.5, headache, severe body aches, redness and swelling at the site of injection. |
| 48 | 2021-01-10 | numbness |
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine...
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Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
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| 48 | 2021-01-10 | pain, weakness |
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and...
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Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
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| 48 | 2021-01-10 | weakness |
Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea,...
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Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea, loss of appetite lasting approximately 72 hours
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| 48 | 2021-01-11 | pain |
Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of we...
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Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of weird headache; body aching; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. Medical history included depression, had hip surgery last year (from 2020) and anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety and depression. esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), on regular basis naproxen sodium (ALEVE) and paracetamol (TYLENOL) because of her hip. Patient was calling because she was vaccinated yesterday, 03Jan2021. Patient was a nurse and she got the COVID Vaccine yesterday. she wanted to go into the symptom checker or whatever because she was having, she woke, she wasn't (incomplete sentence). she had a difficult time sleeping last night. She woke up like with all her joints start just achy and she did not have a great time. she wanted to report her symptoms. patient have other things. No really big co-morbidities, like, she had depression. she had some body issues like she had a "torn labor" and stuff like that but that needs to be repaired but not like blood pressure, diabetes, none of those things. she had hip surgery last year. she took two Aleve in the morning and two 500 Tylenol. And she took one more Aleve in the evening and two more Tylenol. As of causality, patient stated she believe so. It's much more intense than it was, than she was feeling yesterday. she definitely could feel it after she had the vaccination. she got like this aching all up her spine and sort of the weird headache for about (incomplete sentence). it was for the rest of the day about an hour after she got the vaccination. She was a little too un-tuned with her body aching. Consumer stated, "Is there, I mean, more I was calling to register with that CDC thing or whatever to report, you know just what's happening. I figured it was probably, kind of part of the research study or whatever for symptoms and tracking and all that. Is that what I am doing as well too by doing this or is that something separate?" When probed if reported through CDC questionnaire, consumer stated, "No, I went onto the website and it said that on CDC website the worst thing and it said that you needed a code or something a key code to get into the program and I don't. Is this where the reporting is going or how do I register with the (app Name) or whatever? Is that what I did by telling you what's going on?" When informed about the role of Pfizer Drug Safety, consumer stated, "I did not understand that safety report or I figured that we were like also assisting in some kind of research trial type thing too. Are they going to call me or no? Is this the last time I'm hearing from anyone?" No investigation assessment. No Lab Work. No Treatment. Outcome of the events was unknown.
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| 48 | 2021-01-11 | dizziness, numbness, weakness |
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl...
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I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
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| 48 | 2021-01-11 | dizziness | Patient reports dizziness 3 hours after getting vaccination and nausea. Dizziness has since resolved |
| 48 | 2021-01-11 | dizziness |
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes s...
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Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed dizziness and throat tightness. She developed erythema across her chest. BP 180/108. O2 sats 98%. No SOB or difficulty breathing
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| 48 | 2021-01-11 | seizure | Pt had a strong seizure |
| 48 | 2021-01-11 | pain |
Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, c...
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Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, chills, axillary lymph node tenderness and swelling, fever (Tmax 102.2). EE reports she called off of work Monday but later came to work later at approximately 09:00. EE reports Monday resolution of all symptoms except still worsening lymph node tenderness and swelling. EE reports she emailed Woodlands EH RN and advised to contact HR vaccine support line to notify of adverse reaction. EE report she filled out V-safe. Last day of work and shift - ?currently working today Home remedies? - rest and motrin (last dose at 8:30 PM on Sunday 1/10) Any improvement? ? EE reports resolution of all symptoms except lymph node swelling and tenderness Recommendation? EE encouraged to rotate Tylenol and motrin q3h and to contact PCP for appointment.
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| 48 | 2021-01-11 | pain |
developed fever day after vaccination. fever reduced with medication, but then later developed ache...
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developed fever day after vaccination. fever reduced with medication, but then later developed aches, fatigue and chills
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| 48 | 2021-01-12 | tingling |
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa...
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11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
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| 48 | 2021-01-12 | pain |
2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; Th...
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2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) intramuscularly at Left arm on 05Jan2021 12:00 at SINGLE DOSE for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included allergies to Sulfa, mild ragweed. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC ALLERGY), estradiol (VIVELLE DOT). The patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for COVID-19 immunization. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. Adverse events reported as "2nd shot, 12 hrs after body aches, 24 hrs after fevers high 102.5, rigors and felt was burning up". Adverse event start date was reported as 06Jan2021 06:00AM. No treatment received for the events. Outcome of the events was recovered in Jan2021. Information about Batch/Lot number has been requested.
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| 48 | 2021-01-12 | pain |
Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right a...
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Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right arm pain where I received the injection. That evening/night the symptoms progressed to headache and severe chills through the night.
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| 48 | 2021-01-12 | dizziness |
Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. ...
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Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. It restocked just as quickly, lasted 3-5 min
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| 48 | 2021-01-12 | pain, migraine |
Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours ...
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Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours Still slight headache
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| 48 | 2021-01-12 | pain, dizziness |
Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vo...
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Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vomiting, mind splitting headsche
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| 48 | 2021-01-12 | pain | Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla |
| 48 | 2021-01-12 | swollen extremities, pain in extremity, pain |
Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx....
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Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx. 1430, progressively worsened.
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| 48 | 2021-01-12 | pain, dizziness |
Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to fe...
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Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to feel nauseous at first then I had chest pain, headache, chills, back pain, body aches (muscle pain) and dizziness
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| 48 | 2021-01-12 | tingling |
Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, ...
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Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, then spread to right arm. Described sensation as 'what it feels like when you sleep on your arm funny'.-Mild
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| 48 | 2021-01-12 | weakness, tenderness |
The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms w...
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The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms were pain, weakness, tenderness of shoulder joint and upper arm
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| 48 | 2021-01-12 | pain in extremity, tremor | Woke up at 12:30 am with severe chills and shaking. Headache, muscle aches, sweating and sore arm |
| 48 | 2021-01-13 | dizziness |
After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, g...
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After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
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| 48 | 2021-01-13 | numbness | Bilateral mild facial numbness. Intermittent. No weakness. |
| 48 | 2021-01-13 | dizziness, pain |
Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise ...
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Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise my arm/arm weakness; Pain was at a 10 and I had to go to the ER for care; Fatigue/tiredness; This is a spontaneous report from a contactable other HCP (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 30Dec2020 14:15 at single dose in Left arm for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Breast cancer, Hypertension (HTN), high cholesterol, lymphedema, endometriosis, hysterectomy, myomectomies x 2, anxiety, seasonal allergies, hx of pleurisy x 3. Known allergies included adhesive glue in tape and bandaids, pollen, dust, pet dander. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram, losartan potassium 50 mg, anastrozole (ARIMIDEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Day 1-3 Injection site pain Day 6-7-muscle pain, joint pain, headaches, dizziness, nausea, unable to raise my arm/arm weakness, pain was at a 10 and had to go to the ER for care, fatigue/tiredness. All the events were reported onset on 06Jan2021 18:00. AE resulted in Emergency room/department or urgent care. Received Morphine, Muscle relaxer, steroid via IV, RX as treatment. The events were assessed non-serious.
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| 48 | 2021-01-13 | weakness, dizziness, pain |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-13 | dizziness, tingling |
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience...
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Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
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| 48 | 2021-01-13 | tingling |
Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx wi...
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Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx with Benadryl, Pepcid. solumedrol IV. : with sx resolution - observed for 4 hrs in ED & d/cd
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| 48 | 2021-01-13 | pain |
H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underar...
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H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underarm area of affected side. Symptoms have lasted from about 10 hours after the dose and are continuing now (82 hours after the dose)
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| 48 | 2021-01-13 | dizziness |
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at...
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Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
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| 48 | 2021-01-13 | tingling | Reported heart rate of 108, a week of paresthesias. Symptoms resolved |
| 48 | 2021-01-13 | pain |
got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painfu...
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got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painful, headache and body ache. Took a day off today.
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| 48 | 2021-01-13 | dizziness |
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ...
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knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
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| 48 | 2021-01-13 | tingling |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-14 | tremor | "11p that night I had a 101 -102 temp, chills, headache, hard shakes" |
| 48 | 2021-01-14 | pain in extremity |
"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have ex...
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"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have extreme fatigue. My arm was sore for a couple of days only. The first vaccine was on 12/17/20 and i had 11 days of nausea afterwards"
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| 48 | 2021-01-14 | tingling |
At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting abou...
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At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting about 1 sec each time.
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| 48 | 2021-01-14 | pain |
Body, muscle and joint pain; Body, muscle and joint pain; Body, muscle and joint pain; Chills; Tired...
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Body, muscle and joint pain; Body, muscle and joint pain; Body, muscle and joint pain; Chills; Tired; This is a spontaneous report from a non-contactable healthcare professional. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (13:00) (Lot number: EK5730; Expiration date was not reported) and the second dose on 07Jan2021 (07:00) (Lot number: EL0140; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. Medical history included sulfa allergy. Concomitant medications included colecalciferol (VITA D) and magnesium sulfate (MG). On 07Jan2021 (19:30), the patient had body, muscle and joint pain; chills; and tired. The patient did not receive any treatment for the events. The patient's COVID test was negative on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. The outcome of the events, 'body, muscle and joint pain', 'chills' and 'tired', was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 48 | 2021-01-14 | pain |
Fever; body aches; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old fem...
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Fever; body aches; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 22Dec2020 11:30 to 22Dec2020 11:30 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, erythromycin, vancomycin and cipro; all experienced allergies. The patient had fever, body aches and fatigue on 01Jan2021. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
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| 48 | 2021-01-14 | pain |
Flu like symptoms severe chills, fever of 102, headache, body aches, fatigue. Had second COVID, had ...
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Flu like symptoms severe chills, fever of 102, headache, body aches, fatigue. Had second COVID, had fever about 100, chills, body aches, chills, headache that lasted for two days.
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| 48 | 2021-01-14 | pain, pain in extremity, dizziness |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-14 | pain, weakness |
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday...
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Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
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| 48 | 2021-01-14 | tingling | Sévère arthralgia, not able to walk. Facial paresthésie. Extreme fatigue, chills and fever |
| 48 | 2021-01-14 | tingling |
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co...
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Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
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| 48 | 2021-01-14 | lethargy, pain in extremity |
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w...
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day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
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| 48 | 2021-01-14 | weakness, tingling |
severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness...
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severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
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| 48 | 2021-01-15 | difficulty speaking |
About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it ...
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About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
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| 48 | 2021-01-15 | pain in extremity, pain |
I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp ...
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I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp other side effects body aches, joint pain, nausea, sore arm.
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| 48 | 2021-01-15 | tingling |
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res...
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L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
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| 48 | 2021-01-16 | pain |
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat...
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A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
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| 48 | 2021-01-16 | weakness, dizziness, tingling | Dizzy, weakness, tingling in lips and fingers, increased heart rate |
| 48 | 2021-01-16 | dizziness |
Severe myalgia, headache, dizziness, fatigue, nausea, GI cramping, chills for 36 hours Headache pers...
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Severe myalgia, headache, dizziness, fatigue, nausea, GI cramping, chills for 36 hours Headache persistent through today mild myalgia persistent through today
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| 48 | 2021-01-16 | pain in extremity | Temperature 102 Fatigue Sore arm Chills |
| 48 | 2021-01-17 | tingling, pain |
At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard....
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At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard. It was causing a tingling in my arm, like a pinched nerve and was painful to keep my arm in a relaxed position. The node was visible if I lifted my arm above my head. With a dose of ibuprofen, the swelling reduced but it was still palpable and painful for the next 18 hours. By the 72 hour vaccine mark, all symptoms were gone.
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| 48 | 2021-01-17 | feeling cold | Chills, muscle pain, tiredness, injection site pain, feeling malaise |
| 48 | 2021-01-17 | pain |
Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4...
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Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
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| 48 | 2021-01-17 | feeling hot, tingling, dizziness |
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la...
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I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
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| 48 | 2021-01-17 | difficulty speaking |
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, ...
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Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320. Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO. Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
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| 48 | 2021-01-17 | tingling |
tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on ...
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tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on the right side of my face were noticeably weaker; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 23Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at Public Health Clinic/Veterans Administration facility, age at vaccination was 48-years-old. No other vaccine was received in four weeks. Medical history included gastrooesophageal reflux disease (GERD). Known allergies included levofloxacin (LEVOFLOXACIN), pethidine hydrochloride (DEMEROL), phenobarbital, cefalexin monohydrate (KEFLEX), charithromycin (BIAXIN). Concomitant medications included dexlansoprazole (DEXILANT), estradiol, phentermine, ergocalciferol (VIT D), calcium. The patient was not tested for covid prior or post vaccination. On 23Dec2020 at 04:45 PM, after leaving the clinic, the patient felt tingling sensation in right eye and mid cheek area. Within 1.5 hours, muscles on the right side of her face were noticeably weaker. Unable to wink, or scrunch right eye. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with prednisone. Outcome was recovering.; Sender's Comments: Based on a close temporal relationship causality between events "tingling sensation in right eye and mid cheek area" and "muscles on the right side of her face were noticeably weaker" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-19 | numbness, feeling hot, dizziness |
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. S...
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10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
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| 48 | 2021-01-19 | lethargy |
14 hours post vaccine, mild muscle pain. 18 hours post vaccine began: lethargy, temp 99.5, joint pai...
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14 hours post vaccine, mild muscle pain. 18 hours post vaccine began: lethargy, temp 99.5, joint pain, muscle aches.
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| 48 | 2021-01-19 | pain, tremor, dizziness |
Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheade...
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Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheadedness, dizziness, mild intermittent aches and neck pain. Approximately 12-13 hours post dose, reporter developed serious systemic aches and pains, uncontrollable shaking, chills, nausea, vomiting, and developed a fever of up to 103.1. These more severe symptoms lasted approximately 3 hours and were treated with acetaminophen and ibuprofen only.
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| 48 | 2021-01-19 | feeling hot |
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl...
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Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
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| 48 | 2021-01-19 | pain, weakness |
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade feve...
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Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness. It lasted for 2 days.
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| 48 | 2021-01-19 | pain | Fever, body aches, nausea, vomiting, injection site pain |
| 48 | 2021-01-19 | pain |
Had fever up to 100.4; chills; body aches; This is a spontaneous report from a contactable physician...
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Had fever up to 100.4; chills; body aches; This is a spontaneous report from a contactable physician. A 48-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular 09Jan2021 10:00 am in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. Facility type vaccine was in hospital. Other medications in two weeks was none. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient had fever up to 100.4, chills, body aches on 10Jan2021 09:00 AM. No treatment was received for the events. Outcome of events were recovering. Information on the batch/lot number has been requested.
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| 48 | 2021-01-19 | pain | Headache occurred, body aches, chills, nausea, and fever of 99.4 |
| 48 | 2021-01-19 | migraine, pain |
Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, ex...
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Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, extreme fatigue. Lasted for 30 hrs. Fatigue remained another 24hrs. Felt like bad cold or mild flu. I treated with over the counter medication after my physician said that was appropriate. Still worth getting the vaccine! I?m thankful I could receive it.
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| 48 | 2021-01-19 | pain |
SYMPTOMS STARTED MORNING OF 1/18: BODY ACHES, CHILLS. 12MD FEVER (101);2PM NAUSEA; AT NIGHT, HEADACH...
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SYMPTOMS STARTED MORNING OF 1/18: BODY ACHES, CHILLS. 12MD FEVER (101);2PM NAUSEA; AT NIGHT, HEADACHE AND NAUSEA. TUESDAY 1/19, MORNING NAUSEA. FELT BETTER TUESDAY AFTERNOON.
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| 48 | 2021-01-19 | pain |
diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer ...
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diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: Mar2021), via an unspecified route of administration on the left arm, from 05Jan2021 at a single dose for Covid-19 immunisation. Medical history included blood pressure (abnormal). Concomitant medication included ongoing hydrochlorothiazide for blood pressure. On 06Jan2021, the patient has had body aches, headache and no appetite. On 08Jan2021, she had diarrhea. She was going to work today but was unable to because she had to run to the bathroom. She has gone to the bathroom 6 times. She called her doctor at 7:30am but has not heard back. She is unsure what to do. She is asking if these are side effects of the vaccine. She is unsure if the lot number on the card is SK4176 or PK4176. Outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 48 | 2021-01-19 | pain |
injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node...
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injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself. The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation. Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
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| 48 | 2021-01-19 | numbness |
mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning fro...
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mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning from left shoulder to the top of the head and moderate to severe headache
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| 48 | 2021-01-21 | pain | I experienced a low grade fever for 24 hours, body aches |
| 48 | 2021-01-21 | swollen extremities | Lymphadenopathy, right axilla - moderate swelling with pain. |
| 48 | 2021-01-21 | numbness | Patient experienced numbness in left side of face |
| 48 | 2021-01-23 | difficulty speaking, dizziness, speech disorder |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | pain |
01.15.21 nauseous, headache with Fever with chills. 01.20.21 fever with chills still have chills an...
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01.15.21 nauseous, headache with Fever with chills. 01.20.21 fever with chills still have chills and body aches.
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| 48 | 2021-01-24 | swollen extremities |
23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe...
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23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe HA, site of injection-left deltoid-swollen-swollen behind neck-lymph nodes-she said Motrin-HELPS
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| 48 | 2021-01-24 | pain |
Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at...
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Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at injection site.
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| 48 | 2021-01-24 | pain |
Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vacc...
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Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vaccine.
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| 48 | 2021-01-24 | dizziness |
Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able t...
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Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able to return to full duty.
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| 48 | 2021-01-24 | pain in extremity | Left arm pain leading to chest wall pain with pmhx of angina. 6/10 pain radiating to left neck, SOB. |
| 48 | 2021-01-24 | dizziness, tingling |
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a...
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Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
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| 48 | 2021-01-24 | vertigo, dizziness | Vertigo for 3 hours intermittently, then nausea and mild dizziness from 7am- 5pm |
| 48 | 2021-01-25 | vertigo |
Covid/Pfizer vaccine #2 given approx 12:20 pm. Woke approx 1 am with shaking chills, HA, vertigo,103...
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Covid/Pfizer vaccine #2 given approx 12:20 pm. Woke approx 1 am with shaking chills, HA, vertigo,103.4fever.
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| 48 | 2021-01-25 | pain in extremity |
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report...
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Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | weakness |
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B...
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My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
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| 48 | 2021-01-25 | dizziness |
Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were eleva...
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Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were elevated and she stated to feel short of breath. Rapid response team responded and the patient was taken to the ED for evaluation.
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| 48 | 2021-01-25 | tingling |
Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a con...
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Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | weakness | Sore Injection Site, Neck Pain, Nausea and Weakness |
| 48 | 2021-01-25 | tremor, lightheadedness |
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ...
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Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
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| 48 | 2021-01-25 | dizziness |
Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes...
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Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes. No further symptoms or treatment.
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| 48 | 2021-01-25 | lightheadedness, pain |
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night...
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Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly. Continued with tachycardia for several days and mild shortness of breath for two days. That evening, had new onset RUQ abdominal pain for 2-3 hours that resolved.
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| 48 | 2021-01-25 | pain in extremity, weakness, pain |
extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which afte...
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extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which after the second dose remains a dull ache now at two weeks and 3 days after the second dose. Still have severe fatigue. I want to sleep all day.
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| 48 | 2021-01-26 | pain | Chills, aches, headache, tiredness |
| 48 | 2021-01-26 | feeling cold, tremor, pain |
First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with...
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First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with burning pain. Was told is was shingles but wasn?t treated. Was told to get the second vaccine in the opposite arm to see if the same thing happens. Received 2nd injection in left arm and ended up with full blown symptoms of COVID. Uncontrollable shakes, cold, fever, severe body aches, cough, diarrhea and the rash still remains. As of today, I have an upper respiratory infection as well as the open rash, which the PCP listed has taken control of and deemed the cause side effects of the second injection.
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| 48 | 2021-01-26 | numbness, pain in extremity |
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest...
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Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
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| 48 | 2021-01-26 | bell's palsy |
Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects. On Frid...
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Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects. On Friday, 1/22, reporter began experiencing issues blinking. Saturday morning, 1/23, side effects expanded to her mouth. She called a 24/7 health hotline and was diagnosed with Bell's Palsy. She began prednisone Saturday afternoon (1/23). Symptoms persist, but do not seem to be progressing. Has been to her PCP who confirmed initial diagnosis and will schedule appt with endocrinologist to address change in blood sugars with prednisone. Received the vaccine in her right arm, which is the same side of her face affected.
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| 48 | 2021-01-26 | pain in extremity | Sore Arm, Fatigue, General feeling of sick, Hives, |
| 48 | 2021-01-26 | numbness | Systemic: cheek numbness, resolved with 25 mg of benadryl |
| 48 | 2021-01-27 | weakness, tingling |
severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weaknes...
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severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma. There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
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| 48 | 2021-01-28 | tingling, numbness |
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tinglin...
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Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 48 | 2021-02-04 | facial paralysis, slurring, numbness |
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton...
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it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-08 | pain in extremity |
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in t...
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Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-09 | pain |
Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to h...
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Developed mid to right sided upper abdominal pain that radiated into back on 12/31/20, admitted to hospital on 1/2/21 for pancreatitis along with 2 other admissions (1/16/21 & 1/30/21) for same abdominal pain radiating into back.
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| 48 | 2021-02-12 | pain in extremity |
Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), bl...
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Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), blood in urine, pain in all major joints. difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized inpatient for 4 days. I was diagnosed with RHABDOMYOLYSIS, ABNL LIVER FUNCTION STUDY. CREATINE KINASE TEST OUTCOME WAS AT 41000.
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| 48 | 2021-02-16 | numbness |
Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report...
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Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-02-16 | weakness |
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ...
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Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
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| 48 | 2021-02-21 | pain in extremity |
Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old...
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Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and sore arm on 27Jan2021. The outcome of the events was reported as unknown. Information about Lot/ Batch has been requested.
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| 48 | 2021-02-21 | pain in extremity |
I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Har...
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I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Hard raised bump at injection site.
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| 48 | 2021-02-21 | numbness |
I have numbness on the left lower side of my face. It is faint, however, noticeably different from t...
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I have numbness on the left lower side of my face. It is faint, however, noticeably different from the right side with no symptoms.
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| 48 | 2021-02-21 | pain in extremity |
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende...
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arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-02-21 | pain in extremity, pain | swollen of the lymph node, pain on left arm that radiates to upper back |
| 48 | 2021-02-22 | pain |
I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I fe...
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I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I felt fatigue and body aches, dull Headache. In the morning I was nauseus. The symptoms lasted for 24 hours.
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| 48 | 2021-02-22 | tingling | Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash. |
| 48 | 2021-02-22 | numbness |
Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SO...
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Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SOB, wheezing, sweating, and numbness on left side from face to arm. Pt was given oxygen and 0.3mg of epinephrine was given intramuscularly at 12:05pm, followed by 25mg of diphenhydramine intramuscularly at 12:08, both administered by RN on site. Paramedics arrived at the scene at 12:05pm and took over monitoring of pt; pt was taken to ambulance at 12:10pm
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| 48 | 2021-02-22 | pain in extremity |
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa...
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Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
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| 48 | 2021-02-23 | pain in extremity, dizziness, numbness | Headache and dizziness Diarrhea Nauseated Pain in arm and numbness from shoulder to elbow Fatigue |
| 48 | 2021-02-24 | pain |
Headache; Fever; Body aches; Fatigue; stiffness in neck; This is a spontaneous report from a contact...
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Headache; Fever; Body aches; Fatigue; stiffness in neck; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine 2 dose 2 days ago on Tuesday and from Tuesday night, she had pretty significant headache, fever, body aches, fatigue, and stiffness in neck. The patient wanted to know if that is normal and how long they last. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 48 | 2021-03-02 | tingling |
mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; Th...
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mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on the left arm, on 31Jan2021 13:30, at single dose, for covid-19 immunization. Medical history included penicillin allergy. Concomitant medications included temazepam; spironolactone and; silybum marianum (MILK THISTLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received the vaccine in the hospital. It was reported that shortly after the vaccination, on 31Jan2021 the patient experienced mild tinging in her left arm that went away; but when she woke-up she noticed tingling in her feet and they also feel cold on 31Jan2021. The outcome of the event mild tingling in her left arm was recovered on 31Jan2021. The outcome of the events tingling in her feet and they also feel cold was unknown. The patient has not been COVID-tested post-vaccination.
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| 48 | 2021-03-07 | pain in extremity, feeling hot |
fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable hea...
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fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.
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| 48 | 2021-03-10 | dizziness, pain in extremity |
COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat;...
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COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
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| 48 | 2021-03-14 | feeling cold |
On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch soun...
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On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch sound like static. It hasn?t gone away since then. Im seeing an ENT on 3/16/21 to have this checked. About 25 minutes after my covid shot I felt a strong cold feeling on the top of my head for about 30 -60 minutes . It went away. Now I wonder if this was also related.
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| 48 | 2021-03-14 | dizziness |
nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This i...
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nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm, on 05Feb2021 at 11:45 (at the age of 48-years-old) at a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included fingolimod hydrochloride (GILENYA), baclofen (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies and ibuprofen (MANUFACTURER UNKNOWN) and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and fatigue on 05Feb2021 and nausea, vomiting, headache, feeling feverish (no fever), and feeling beat up on 06Feb2021 at 13:30. The events were reported as non-serious. The clinical course was reported as follows: Within one to two hours (as reported), on and off, the patient felt dizziness and fatigue. After 26 hours (as reported), the patient felt nausea, vomiting, headache, fatigue, feeling feverish (no fever) and feeling beat up. The feeling beat up lasted 12-14 hours and the headache lasted 2 days. The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue, nausea, vomiting, and feeling feverish (no fever) was recovered on an unspecified date, feeling beat up was recovered on 07Feb2021, and headache was recovered on 08Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-03-14 | dizziness |
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ...
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out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
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| 48 | 2021-03-14 | pain, pain in extremity, tingling |
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore...
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pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
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| 48 | 2021-03-15 | numbness, dizziness |
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes...
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Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
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| 48 | 2021-03-17 | pain |
Patient received COVID-19 vaccine on 1/4/2021. Later that day developed chills/sweats, body aches, ...
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Patient received COVID-19 vaccine on 1/4/2021. Later that day developed chills/sweats, body aches, cough, nasal congestion, sore throat and shortness of breath. She continues to have shortness of breath and has not been able to return to work.
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| 48 | 2021-03-21 | tremor |
I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactab...
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I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
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| 48 | 2021-03-22 | seizure, tremor | Seizure the next day plus headaches, tremors and vomiting. |
| 49 | 2020-12-31 | weakness, dizziness |
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1...
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mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
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| 49 | 2021-01-01 | numbness |
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ...
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12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
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| 49 | 2021-01-02 | dizziness |
2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history o...
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2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history of anxiety and has been seen before for anxiety attacks. Pt denies chest pain, shortness of breath or pain. 2:45 pm pt evaluated by EMS BP 138/78, Pulse 98. pt reports feeling better. 2:55 pm pt declined transport to ED, signed out AMA. Pt was escorted out to car.
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| 49 | 2021-01-03 | tremor, feeling hot |
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute...
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10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
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| 49 | 2021-01-03 | pain in extremity, swollen extremities, pain, vertigo |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | dizziness, weakness |
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S...
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Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
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| 49 | 2021-01-03 | pain in extremity |
Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigu...
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Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.
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| 49 | 2021-01-03 | facial paralysis, numbness |
On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste li...
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On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste like cotton on the left side of my mouth/ tongue. As the day progress, I noticed I am having numbness left side of my face and mouth, unable to sip from a straw on the left side of my mouth, I am having facial droop that prompted me to to the ER . At ER same day my left eye is not blinking as my right eye. I was prescribed to take antiviral , steroids and eye meds. TODAY- 1/4/21, I am still having same symptoms and my left eye , feels grainy/ needle pricking inside. Left eye vision more blurry.
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| 49 | 2021-01-03 | numbness |
Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency,...
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Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
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| 49 | 2021-01-03 | tingling |
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ...
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Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
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| 49 | 2021-01-03 | tingling |
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou...
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Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
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| 49 | 2021-01-03 | pain in extremity | Very sore arm, required Tylenol Moderate fatigue Sore are resolved next day Fatigue continues |
| 49 | 2021-01-03 | dizziness, weakness | headache, weakness, brain fog, confusion, dizziness. weakness in limbs |
| 49 | 2021-01-03 | pain in extremity, pain |
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim...
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pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
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| 49 | 2021-01-04 | pain |
By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed ar...
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By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed around 10 pm, I woke the following day around 4pm. This is very unusual for me. Confined to not feel well into the next day , but by that evening I felt better.
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| 49 | 2021-01-04 | dizziness |
Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregna...
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Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in the last four weeks. Concomitant medications included omeprazole (PRILOSEC), metoprolol, levothyroxine sodium (SYNTHROID), aciclovir sodium (ACYCLOVIR VIAL), and meloxicam (MOBIC). The patient previously had allergies with morphine. On 28Dec2020, the patient experienced dizziness 12 hours after injection with outcome of recovering. The patient did not receive treatment for the reported adverse event. The report was considered non-serious. Information on the batch/lot number has been requested.
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| 49 | 2021-01-04 | numbness, dizziness |
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue are...
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Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
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| 49 | 2021-01-04 | pain |
I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report f...
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I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for seasonal allergy. On 29Dec2020 (within a few minutes), she broke out and was sweating. She had sweat at her face and sweated in her clothes. The patient also have a terrible headache, her body hurt and have chills. The patient did not receive any treatment for the events and was going to ask if she can take diphenhydramine (BENADRYL) as she do not know what to do. She doesn't know if she can take medicine because it was terrible. Outcome of the events were unknown.
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| 49 | 2021-01-04 | numbness, tingling |
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af...
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I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
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| 49 | 2021-01-04 | pain, pain in extremity |
ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO...
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ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.
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| 49 | 2021-01-04 | pain |
Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is...
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Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is tender. Also notice mild body aches at this time. Sunday came home from work w fever chills headache and vomiting
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| 49 | 2021-01-04 | dizziness, weakness |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | pain in extremity, migraine, pain |
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an...
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swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
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| 49 | 2021-01-04 | weakness |
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ...
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throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
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| 49 | 2021-01-05 | lethargy |
A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and i...
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A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.
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| 49 | 2021-01-05 | numbness, pain in extremity, tingling |
After receiving the injection in the right arm, the patient began to feel pain and burning at the in...
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After receiving the injection in the right arm, the patient began to feel pain and burning at the injection site in the right deltoid with spreading down to her hand along with localized redness at the injection site. She was given 50 mg of diphenhydramine and subsequently developed facial flushing and a feeling of numbness/tingling in both arms and hands. At this time, about half an hour had elapsed after the injection, so she was referred to the hospital emergency department from the hospital vaccine pod for additional monitoring. No additional interventions were given in the emergency department, she was discharged home after 3 hours of monitoring. Symptoms had improved with time.
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| 49 | 2021-01-05 | pain in extremity | Chills,joint pain,muscle aches,nauseated, headache, sore arm |
| 49 | 2021-01-05 | pain |
Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all l...
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Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all lasting apx 16hrs. Then the next 24 hrs just mild HA and some body aches.
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| 49 | 2021-01-05 | dizziness, feeling hot, pain in extremity, tremor |
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si...
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I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
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| 49 | 2021-01-05 | feeling cold, pain |
I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itch...
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I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .
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| 49 | 2021-01-05 | dizziness |
Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine admi...
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Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine administration
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| 49 | 2021-01-05 | feeling hot | THROAT TIGHTNESS, FINGERS WARM. EPI GIVEN. TRANSFERED TO ER |
| 49 | 2021-01-05 | migraine, tingling |
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to...
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UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
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| 49 | 2021-01-06 | dizziness |
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed...
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12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
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| 49 | 2021-01-06 | pain in extremity | 9 x 5 cm area of raised redness and pain left arm starting on on day 8 |
| 49 | 2021-01-06 | dizziness |
?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 1...
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?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm. Pfizer vaccine Lot EL0142. 0.3ml IM, left deltoid. states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21. Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve. PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness. A picture of the affected area is available if requested
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| 49 | 2021-01-06 | dizziness |
@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained ...
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@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips. Â @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,"I feel a lot better." Â Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days. Â Pt advise to call if s/sx return or get worse. Â Allergies updated and Covid-19 vaccine added, suggested "not recommended for 2nd dose" and 2nd dose appt canceled.
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| 49 | 2021-01-06 | migraine |
About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All sympt...
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About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All symptoms lasted about 22 hours. I still have a minor headache and fatigue
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| 49 | 2021-01-06 | pain |
About an hour after the injection I had pain and burning going down my left side and in the left sid...
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About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
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| 49 | 2021-01-06 | dizziness | Dizziness |
| 49 | 2021-01-06 | dizziness, weakness, tingling, pain in extremity |
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, g...
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Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
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| 49 | 2021-01-06 | pain | Fever and body aches. Stayed Home |
| 49 | 2021-01-06 | pain, weakness |
Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02...
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Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin. Monday-too weak to work. Body aches, headache. Monday severe ABD cramps-heating pad to help/nauseated. Tuesday diarrhea starts. Wednesday-left side of her back-pain-diarrhea & Tired. No SOB. Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.
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| 49 | 2021-01-06 | tremor | Fever, chills, shaky |
| 49 | 2021-01-06 | dizziness, pain in extremity | Headache, Myalgia, ARM PAIN,CHILLS,LIGHT HEAD Narrative: |
| 49 | 2021-01-06 | pain in extremity |
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm...
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Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
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| 49 | 2021-01-06 | weakness, dizziness |
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad...
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Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
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| 49 | 2021-01-06 | pain |
Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4...
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Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021. Vaccine given at 7:30 AM on 1/6/2021. Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved. No treatments given.
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| 49 | 2021-01-06 | numbness, tingling |
Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of ...
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Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.
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| 49 | 2021-01-06 | tingling, numbness |
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dos...
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Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
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| 49 | 2021-01-06 | weakness | Patient reported weakness and pain in neck and back |
| 49 | 2021-01-06 | dizziness, numbness, tingling |
Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the l...
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Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued
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| 49 | 2021-01-06 | tingling, numbness |
Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient ...
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Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient reports the numbness being limited to the bottom of the arm and hand. Patient states to being able to use hand but reports there is numbness and tingling.
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| 49 | 2021-01-06 | feeling hot |
Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; p...
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Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; pulse 84; p ox 99%. Has had same sensation when had allergic reaction to bactrim. Monitored for another 15 -20 minutes; took gatorade. Wanting to go home and take liquid benadryl.
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| 49 | 2021-01-06 | swollen extremities |
Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her arm...
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Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her armpits swelled up that she was not able to put her arm down. It lasted several days.
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| 49 | 2021-01-06 | pain | SWEATS, HEADACHE,BODY ACHES,CHILLS,TEMP .OF 101.1 , |
| 49 | 2021-01-06 | feeling hot, migraine |
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci...
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This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
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| 49 | 2021-01-06 | feeling hot, dizziness |
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i...
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Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
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| 49 | 2021-01-06 | feeling hot |
a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This ...
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a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
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| 49 | 2021-01-06 | numbness, dizziness, tingling |
felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, al...
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felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell
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| 49 | 2021-01-06 | feeling hot |
she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Ta...
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she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
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| 49 | 2021-01-06 | dizziness |
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallo...
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throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 49 | 2021-01-07 | pain in extremity |
01/08 sent email to cancel the second dose. I called her and she states after the first dose after ...
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01/08 sent email to cancel the second dose. I called her and she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She states her resting HR was HR 130 for about an hour but she just sat and waited it out. She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she felt fine the next day except for sore arm.
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| 49 | 2021-01-07 | dizziness |
1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience q...
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1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience quit a bit of pain at the injection site. Arm pain decrease the next day and was able to raise arm without assistance. 1/8/2021 Tired and lightheaded. I felt like I would pass out if I did not sit down. Cannot stand on my feet longer than 30 minutes at a time. Also experience shortness of breath.
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| 49 | 2021-01-07 | feeling hot, pain, migraine |
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver...
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100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
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| 49 | 2021-01-07 | weakness, pain |
Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after inject...
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Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone. -took advil, increase fluids and went to bed to sleep ~ 7 hours
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| 49 | 2021-01-07 | pain in extremity, feeling hot |
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ...
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EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
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| 49 | 2021-01-07 | tingling |
Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the...
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Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the inside of her left wrist; "Needle pokes" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced "needle pokes" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.
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| 49 | 2021-01-07 | pain in extremity, pain |
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ...
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I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
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| 49 | 2021-01-07 | tingling, dizziness, numbness |
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi...
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Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
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| 49 | 2021-01-07 | pain in extremity | Nausea, Headache, Fever, Sweats, Sore Arm |
| 49 | 2021-01-07 | movement disorder, pain | Pain at site, shooting down the arm and unable to lift arm. Shoulder frozen. |
| 49 | 2021-01-07 | tingling |
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/1...
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Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
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| 49 | 2021-01-07 | dizziness |
Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12...
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Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
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| 49 | 2021-01-07 | feeling hot | Throat hurting , really hot Neck Swollen , back of Neck hurt really bad Joint Pains Headache |
| 49 | 2021-01-07 | tingling, dizziness |
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1...
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developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
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| 49 | 2021-01-07 | pain, pain in extremity |
fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhaust...
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fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious. Information on the lot/batch number has been requested.
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| 49 | 2021-01-08 | weakness, pain, movement disorder |
01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills...
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01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache. Needed pain medicine to alleviate pain. Fatigue. 01/09:21: AM: Less body pain , but feeling of heaviness in head; weak. PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several episodes of diarrhea. Feeling like passing out but never did. Loss of appetite. Slowly resolving.
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| 49 | 2021-01-08 | dizziness, feeling cold |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-08 | migraine |
Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into...
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Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.
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| 49 | 2021-01-08 | pain |
Fever and body aches occurred about 10 hours after I received the second dose Fever ranged from 101...
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Fever and body aches occurred about 10 hours after I received the second dose Fever ranged from 101.8 - 100.4 for about 24 hours Treated with Tylenol 650mg every six hours for a total Of three doses
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| 49 | 2021-01-08 | vertigo, dizziness, weakness, inability to speak |
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor...
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Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
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| 49 | 2021-01-08 | feeling hot, pain | Headache chills, feels hot (no fever), body aches, stuffiness, and headache |
| 49 | 2021-01-08 | feeling hot | Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating |
| 49 | 2021-01-09 | pain in extremity, pain |
Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs p...
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Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs post vaccination. Approx 24-30 hrs post vaccination chills and slight headache added and remained until approx 48 hours post. Took Motrin for aches and rested with restricted movement
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| 49 | 2021-01-09 | pain |
Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Head...
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Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Headache, chills, sweating, low grade fever 99.5 all day until about 10:00 pm on 1/8/21. 80% better on 1/9/21 just lower back soreness and mild headache. 100% better on 1/10/21. This was my second vaccine.
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| 49 | 2021-01-09 | pain in extremity |
The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that o...
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The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds. Did not re-occur. Did not seek treatment. Reported to Dr. and no further issues seen.
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| 49 | 2021-01-09 | migraine |
Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had...
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Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
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| 49 | 2021-01-09 | pain |
fever, chills, headache, overall aches. Started 11 hours after receiving vaccination. symptoms (al...
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fever, chills, headache, overall aches. Started 11 hours after receiving vaccination. symptoms (although not as uncomfortable) still continuing at 42 hour mark
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| 49 | 2021-01-10 | lethargy, pain |
1/08/21 I was very fatigued, and a little bit of body aches. 01/09/21 I was very lethargic and had ...
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1/08/21 I was very fatigued, and a little bit of body aches. 01/09/21 I was very lethargic and had body aches, mostly in my joints
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| 49 | 2021-01-10 | tenderness, pain |
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi...
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After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
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| 49 | 2021-01-10 | pain | Fever body aches chills |
| 49 | 2021-01-10 | pain | Fever, body aches, chills, headache, left lower quadrant pain front and back. Lasted 36 hours. |
| 49 | 2021-01-10 | pain | Lymph pain, low grade fever, aches |
| 49 | 2021-01-10 | tenderness |
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti...
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Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
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| 49 | 2021-01-10 | feeling hot |
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte...
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Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
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| 49 | 2021-01-10 | feeling cold | chills exhaustion, headache |
| 49 | 2021-01-10 | pain | chills, aches, lymph pain |
| 49 | 2021-01-10 | feeling cold, speech disorder |
her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all ...
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her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.
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| 49 | 2021-01-11 | pain |
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins We...
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1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy. Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head. Headache constant top of head. 10:45am spots and vision blurry. Felt very sick. Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did not see black spots. Monday increase black spots. Saw an eye doctor.
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| 49 | 2021-01-11 | feeling hot |
99 yo obese DMII smoker reported during post-vaccination monitoring for Pfizer COVID 19 that she wa...
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99 yo obese DMII smoker reported during post-vaccination monitoring for Pfizer COVID 19 that she was experiencing a burning sensation without pain in her neck, hips and along the spine area of her lower back. She reported feeling warm but stated it was likely a hot flash. She reported that when she has a flu shot she has localized arm burning sensation similar to this burning. Denies difficulty breathing, or swelling of any portion of her body. Patients states she is comfortable self-monitoring and plans to go to work. Patient released to self after monitoring for 1 hour. If patient later seeks medical care, we requested she inform us of the outcome.
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| 49 | 2021-01-11 | tenderness |
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou...
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Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
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| 49 | 2021-01-11 | pain |
Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by...
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Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by nausea low grade temp. On Sunday about 4am I started vomiting with diarrhea, joint pain, Headache, BP of 168/109 and temperature of 100.1.
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| 49 | 2021-01-11 | pain, pain in extremity |
Pain in left arm began within 30 min. of injection and has lasted over 24 hours with radiation down ...
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Pain in left arm began within 30 min. of injection and has lasted over 24 hours with radiation down into elbow, wrist, hand and fingers.
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| 49 | 2021-01-11 | pain in extremity |
Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other ...
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Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other HCP (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant. Patient received the first dose on 17Dec2020 05:45 PM also at right arm for covid-19 immunization. Lot number was also EJ1685. The facility type vaccine was hospital. Medical history included Celiac. Concomitant medication included pregabalin (LYRICA), celecoxib (CELEBREX), escitalopram oxalate (LEXAPRO), spironolactone. Known allergies: Penicillin, morphine, lactated ringers. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient experienced Sore arm, headaches at 05Jan2021 06:00 PM with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-01-11 | dizziness, tremor |
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness...
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The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
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| 49 | 2021-01-11 | weakness, pain |
doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her...
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doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her hard; headache; so weak; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date: unknown), via an unspecified route of administration on 06Jan2021 at 12:30 at a single dose for Covid-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day before (06Jan2021) and doesn't feel good in the morning, her body is hurting, and she has a headache. The patient is a CNA and she got the vaccine the day before at around 12:30 and she just got up in the morning, so weak, and her left side hurts. Her body hurts and she doesn't feel good too, reportedly "all the body hurts now, it's like somebody hit her hard". The patient asked if she can take Tylenol or pain medication. After receiving a verbal response, the patient added that she would take Tylenol and pain medication together and hopefully get some sleep. The patient then asked if headache and body ache are normal side effects of the vaccine. The outcome of the events was unknown. Information about batch/lot number has been requested.
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| 49 | 2021-01-12 | dizziness |
2 nd dose : Dizziness, lightheaded, severe headache, fever all night. 1/9/21 Dizziness, lightheaded,...
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2 nd dose : Dizziness, lightheaded, severe headache, fever all night. 1/9/21 Dizziness, lightheaded, nausea. Nausea continues all other symptoms have resolved. 1 dose: no ae to report
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| 49 | 2021-01-12 | dizziness |
About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She repor...
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About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She reported "having waves of dizziness" that "made me feel like she was going to pass out but was clearly not" also reported "dizzy spots" in her vision. She had 3 separate episodes, each lasting about 4-5 minutes each. BP @ onset 100/63, pulse 57, after resolution, 100/62, pulse 62. O2 sat 100%. All symptoms resolved after a total of 30 minutes post vaccination.
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| 49 | 2021-01-12 | tingling, numbness |
Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provi...
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Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provider onsite: NP evaluated the client, advised to wait for another 15 minutes. @0932 per client she is feeling better. Provider onsite advised client to see her PMD if the reaction will get worse. Client left the clinic in Ambulatory stable condition.
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| 49 | 2021-01-12 | dizziness | Dizzy, light headed, hives on left side of neck and chest. |
| 49 | 2021-01-12 | dizziness |
about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No ...
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about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No diarrhea but soft stools. today headache, and fatigue
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| 49 | 2021-01-12 | pain | headache, chills, shivering, muscle aches |
| 49 | 2021-01-13 | pain, numbness |
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on...
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-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
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| 49 | 2021-01-13 | pain |
1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and ches...
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1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache 5:30pm BP 172/109 tachycardia and SOB nausea BP still 185/107 so went to prompt care who sent via ambulance to ER. Given nitro, fluids and morphine. Sent home. Next morning BP 188/118 and 213/122. C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126. PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
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| 49 | 2021-01-13 | pain, weakness |
Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling ...
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Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
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| 49 | 2021-01-13 | pain in extremity |
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p...
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Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
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| 49 | 2021-01-13 | pain in extremity | Patient describes nausea, fatigue and headache. Also has arm soreness, but very mild |
| 49 | 2021-01-13 | numbness |
Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with t...
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Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with the injection but rather 5 minutes after. Lasted about 3 minutes before completely resolving. The right arm numbness returned on 01/01/2021 and persisted through 01/03/2021. Went away and returned on 01/06/2021 then migrated to the left arm. Waxes and wanes and added numbness to bilateral lower legs and feet. Improved with less frequency by 01/14/2021.
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| 49 | 2021-01-13 | pain |
Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a conta...
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Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a contactable nurse. A 49-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 06Jan2021 16:30 at the first single dose for covid-19 immunisation. Medical history included ongoing hypertension , ongoing hypothyroidism , ongoing blood cholesterol increased , Known allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe body aches, headache, nausea, diarrhea, exhaustion on 07Jan2021 03:00. The patient did not receive any treatment for the events. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 49 | 2021-01-13 | numbness |
c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other sympto...
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c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other symptoms noted. Monitored for 30 minutes.
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| 49 | 2021-01-13 | dizziness, pain in extremity |
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery...
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felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
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| 49 | 2021-01-13 | pain | hives from neck to thighs, itchy, aches all over |
| 49 | 2021-01-14 | pain |
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches...
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1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit. *First dose; slight fever of 100 on day 3,4 and pain at injection site.
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| 49 | 2021-01-14 | pain |
1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *f...
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1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *first vaccination; slight fever of 100 on days 3,4.
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| 49 | 2021-01-14 | tingling |
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated s...
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After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
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| 49 | 2021-01-14 | bell's palsy | Bell's Palsy left side |
| 49 | 2021-01-14 | feeling hot, feeling cold |
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i...
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Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
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| 49 | 2021-01-14 | pain |
Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph no...
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Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph nodes began afternoon 1/14/21
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| 49 | 2021-01-14 | pain |
Employee received the first vaccine on 12/18 with no problems. Developed "sinus symptoms" which bega...
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Employee received the first vaccine on 12/18 with no problems. Developed "sinus symptoms" which began on Dec 28, was rapid tested on 12/30 and read as positive. Did well and was due to come back to work when received the second dose of Pfizer vaccine on 1/6. She was symptomatic at the time. The day following the second vaccine, developed temperature, body aches and generalized malaise. Has been out of work since that time. Did see nurse practitioner on Wednesday.
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| 49 | 2021-01-14 | dizziness, weakness |
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI...
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FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
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| 49 | 2021-01-14 | pain, pain | Fever, chills, body ache |
| 49 | 2021-01-14 | dizziness |
Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided...
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Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided Chest pain with difficulty breathing. Patient's chest pain was so bad she thought she was going to die. Was transported to ER via ambulance, had cardiac workup, blood clot workup (had left leg pain the day before incident). Was discharged home on zanaflex and motrin with diagnosis of Chest Wall pain about 4 hours later. Follow up on 1.15.2021 at 1000 and patient doing better but still has chest pain. Will not be getting 2nd COVID vaccination.
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| 49 | 2021-01-14 | pain in extremity, pain |
She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm sorenes...
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She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm soreness which progress to body aches and tongue swelling. I took 50mg of Benadryl and 40 mg of prednisone that I had at home and my symptoms resolve gradually and I felt better the next day
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| 49 | 2021-01-14 | pain | fever, chills, body ache, joint pain. |
| 49 | 2021-01-14 | pain, pain in extremity, swollen extremities |
immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and move...
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immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and movement, then flu like symptoms 1/11-14/21: aches, fatigue, malaise, head ache; on 1/12/21 in the afternoon I noticed right axilla pain in axilla, same level at the upper back/ribcage under the shoulder blade and corresponding pectoralis muscles and swell in axilla and upper pectoralis muscles, I could also palpitate multiple firm and tender lymph nodes at the right axilla.
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| 49 | 2021-01-14 | pain in extremity, pain |
left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day....
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left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day. Outcome: Moderate improvement has continued c/o of mild fatigue and generalized body aches that does interfere with ADL's currently working.
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| 49 | 2021-01-14 | balance disorder, pain in extremity, feeling hot |
the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face...
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the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; I had a short episode of disequilibrium; awoken by intense bilateral leg pain; my legs felt weak the following day; This is a spontaneous report from a contactable Physician who reported for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) for COVID-19 immunisation on 07Jan2021 at 15:30 at single dose in Left arm. Medical history included allergy to penicillin , clindamycin, azathioprine (IMURAN) (known allergies: penicillin, clindamycin, Imuran) , allergy to glove powder and autoimmune disorder (unspecified). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, mycophenolate mofetil (CELLCEPT), folic acid and magnesium. On 07Jan2021 at 17:30 , approximately 2 hours after she received the vaccine, she had a short episode of disequilibrium, then an hour after that (at 18.30) the left side of her face felt heavy, stiff and was palpably warmer than the right side of her face. There were no visible changes to the appearance of her face, and she had normal motor control. This episode lasted for approximately 1-2 hours then gradually diminished. In Jan202, approximately 36 hours after the vaccine, patient was awoken by intense bilateral leg pain. The pain gradually diminished after approximately an hour, but her legs felt weak the following day. Legs were fine on 10Jan2021. In the evening of 09Jan2021 though 10Jan2021, the skin overlying the injection site had an intense prickly "itchy" sensation, there was no rash. Events were all non serious. No treatment administered and final outcome for all the events was reported as recovering.
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| 49 | 2021-01-15 | dizziness, pain in extremity |
Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Diz...
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Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Dizziness Lightheadedness Fatigue Chills Sneezing Sore arm (first 3-4 days). I had a negative COVID test on 1/12/21.
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| 49 | 2021-01-15 | dizziness | SOB, dizziness, headache, fatigue. |
| 49 | 2021-01-15 | pain in extremity, dizziness |
dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued a...
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dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14 took Tylenol and motrin
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| 49 | 2021-01-16 | pain | Fever, chills, aches |
| 49 | 2021-01-16 | lightheadedness |
Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appet...
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Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appetite. Lasted over 4 hs severe, 12 hs moderate
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| 49 | 2021-01-16 | pain in extremity, pain |
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe...
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Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
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| 49 | 2021-01-16 | vertigo, pain in extremity, pain |
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ...
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Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
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| 49 | 2021-01-17 | pain, tingling |
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. ...
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49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
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| 49 | 2021-01-17 | tenderness |
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t...
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swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
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| 49 | 2021-01-19 | pain in extremity |
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte...
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"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
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| 49 | 2021-01-19 | speech disorder, tingling, dizziness, numbness |
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my...
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29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
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| 49 | 2021-01-19 | pain in extremity |
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ...
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: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
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| 49 | 2021-01-19 | pain |
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chil...
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Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30 Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020. The action taken was not applicable.
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| 49 | 2021-01-19 | pain in extremity, weakness |
I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache...
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I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache, fever of 101.2, arm soreness on first day. Today (2nd day) temp of 100, body fatigue/weakness, slight headache, arm soreness, but overall feeling better.
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| 49 | 2021-01-19 | pain, weakness, dizziness |
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ...
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I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
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| 49 | 2021-01-19 | pain in extremity |
Patient reports acute pain at the injection site immediately after vaccination that lasted for an ho...
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Patient reports acute pain at the injection site immediately after vaccination that lasted for an hour and a half, she also had pain up and down her arm and into her neck. She reports numbing/tingling in both cheeks for half an hour after receiving the vaccine. 9 days later she continues to experience pain up and down the injected arm from wrist to shoulder and into her neck. The pain is somewhat relieved by NSAIDs.
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| 49 | 2021-01-19 | tingling |
Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been go...
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Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been going on about 10 mins before she said anything. Benadryl 25mg given @ 1705. Does have allergies to Flu Vaccine, MRI Dye, Vicodin, Buspar, Lisinopril, Suchycin. Celexa, Prev Pack, Lexapro, Penicillin, Hydrocodone, and Fluoxetine. Remains to voice s/s @ 1729. Red Blotchy areas noted to face and neck. Pt states this is normal for her when her anixety level is high. V/S were taken @ 1733 BP-193/105, P-74, R-18, 02-100% on L arm. V/S obtained on R arm @ 1731 BP-193/111, P-76, R-18, O2-100%. States that takes BP meds daily @ night, in which she hasn't taken her meds all day. Takes Amlodipine 5mg, Klonopin 0.5mg, Vit D 1000, MVI, Clartin 5mg, and Zantac 150mg. Stil continues to voice s/s @ 1739. BP remains elevated. Patient sent to ER @ 1740. Pt entered registration @ ER @ 1745. Pt continue to voice s/s of prickling noted to body. Denies SOB nor trouble w/ breathing.
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| 49 | 2021-01-19 | pain in extremity, pain |
Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero sid...
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Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero side effects except arm soreness
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| 49 | 2021-01-19 | numbness |
Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard t...
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Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard time catching my breath, throat became itchy. This lasted for around 35 minutes.
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| 49 | 2021-01-19 | dizziness, pain | dizzy headache chills body aches low grade fever diarrhea |
| 49 | 2021-01-19 | pain |
fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get ou...
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fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get out of bed; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL3248), via an unspecified route of administration in the right arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EK5730) on 19Dec2020 at 11:30 AM in the left arm. The patient's concomitant medications were not reported. On 09Jan2021 10:00 the patient experienced fever, extreme body/ muscle aches, headache, sore throat, can't get out of bed, extremely tired all with outcome of not recovered. The patient received no treatment due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 49 | 2021-01-19 | numbness, tingling |
generalized numbness and tingling down both arms extending from shoulders to fingers, transient sens...
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generalized numbness and tingling down both arms extending from shoulders to fingers, transient sensation of bandlike chest tightening across rib cage, BP 156/94 with pulse oximetry 98, pulse 111. Observed one hour without allergic signs or symptoms and no wheezing.
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| 49 | 2021-01-19 | dizziness, vertigo, lightheadedness |
he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mi...
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he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
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| 49 | 2021-01-20 | tenderness, pain in extremity, pain |
Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot bu...
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Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-20 | pain in extremity, tingling, pain |
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches...
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fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 49 | 2021-01-21 | pain | Achy arm Body Aches Fast heart beat |
| 49 | 2021-01-21 | numbness |
At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied...
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At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied pain. No antidote nor supportive treatment given. After ~40 minutes of observation, minimal numbness and no SOB. Patient left clinic.
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| 49 | 2021-01-21 | pain | Body aches, headache |
| 49 | 2021-01-21 | pain | CHILLS, BODY ACHE. INJECTION SITE SORENESS. |
| 49 | 2021-01-21 | weakness | Fever-around 101.7 had lasted for 36 hours. Chills and extreme muscle pain Weakness |
| 49 | 2021-01-21 | dizziness, unresponsive to stimuli |
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ...
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Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
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| 49 | 2021-01-21 | pain in extremity |
My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pa...
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My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pain was mild but my headaches have not gone away they are usually mild to moderate.
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| 49 | 2021-01-21 | pain, pain in extremity |
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over bod...
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Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021 left axillary lymph node swelling and soreness.
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| 49 | 2021-01-21 | dizziness, pain |
Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I ...
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Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I feel short of breath. I have pounding in my chest. I got dizzy after a bath and almost fell. I am very well hydrated I have drank at least 2 liters of water. I can?t get rid of my headache or body aches. I have taking ibuprofen , Pepcid , zomig for my headache which didn?t help , 600 mg of gabapentin, 20 of prednisone .. I feel like I can?t get enough air.
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| 49 | 2021-01-24 | feeling hot |
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ...
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I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
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| 49 | 2021-01-24 | tenderness | Swollen lymph node/gland w/ tenderness in the left arm Pitt |
| 49 | 2021-01-25 | inability to speak |
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat...
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? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
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| 49 | 2021-01-25 | tenderness |
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.;...
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First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
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| 49 | 2021-01-25 | feeling hot | I have a sudden "hot feeling" in arms and legs that started 2 days ago. |
| 49 | 2021-01-25 | vertigo, migraine, dizziness |
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con...
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migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
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| 49 | 2021-01-26 | pain, weakness |
I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I w...
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I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I woke up sweating profusely and had major chills. My body ached all over and had a hard time sleeping due to all of this the entire evening. I woke up and tried to get ready but quickly realized I was weak, my joints hurt, body ached, headache and couldn't do it. This continued throughout the morning and part of the afternoon. Then around 2pm, I was still tired and achy but my joints didn't hurt as bad and I was able to manage the headache with ibuprofen. The body aches continued through most of the next day (Jan. 23) as well. By Jan. 24th I was perfectly fine and back to normal. I had covid early in the year on Nov. 6 which kept me out of work for almost 3 weeks. These few days were very similar to how I felt when I had covid but not as intense.
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| 49 | 2021-01-26 | dizziness |
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then ...
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Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
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| 49 | 2021-01-26 | pain in extremity, weakness, numbness |
Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndro...
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Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndrome
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| 49 | 2021-01-27 | pain |
Chills; headache; body aches; This is a spontaneous report from a contactable other health professio...
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Chills; headache; body aches; This is a spontaneous report from a contactable other health professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, intramuscular in the right arm, on 12Jan2021 17:00 at a SINGLE DOSE for covid-19 immunization. Prior vaccination, the patient had COVID-19 on an unspecified date. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), rosuvastatin calcium (CRESTOR), colecalciferol (VITAMIN D), ibuprofen, paracetamol (TYLENOL). Patient was not pregnant during vaccination. The patient previously took Tetracycline and Wellbutrin; she experienced allergy to both on unspecified dates. On 13Jan2021 17:00, the patient experienced chills, headache and body aches. outcome of events was recovered. The patient did not receive any treatment due to events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 49 | 2021-01-27 | dizziness, pain |
Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient...
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Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient had headache and tiredness and diarrhea and body aches after 2nd dose covid vaccine. Symptoms progressed to severe headache associated with N/V, dizziness that started 1/28@0800am. The patient admitted to Emergency Room at Hospital on 1/28/21 and diagnosed with aneurysmal subarachnoid hemorrhage. Patient transferred to Medical Center for care.
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| 49 | 2021-01-28 | pain in extremity, pain, dizziness |
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti...
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Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
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| 49 | 2021-01-28 | pain | Fever 101, body aches, chills |
| 49 | 2021-01-28 | swollen extremities |
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph no...
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Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | vertigo |
Headache Vertigo; Headache Vertigo; This is a spontaneous report from a contactable other health car...
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Headache Vertigo; Headache Vertigo; This is a spontaneous report from a contactable other health care professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), intramuscular (left arm) second dose on 14Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included Diabetes and PKD. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686) via Intramuscular left arm first dose on 22Dec2020 08:00 AM for covid-19 immunisation. On 16Jan2021 08:00, the patient experienced headache and Vertigo. The patient did not received treatment for the events. The outcome of the events was recovering.
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| 49 | 2021-01-31 | pain in extremity |
Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees ...
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Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-01 | pain |
Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, ...
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Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
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| 49 | 2021-02-01 | pain |
a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny ...
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a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
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| 49 | 2021-02-02 | lightheadedness, dizziness |
Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath;...
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Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-03 | swollen extremities |
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; a...
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Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-03 | facial paralysis |
was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to ...
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was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020. Information on the lot/batch number has been requested.
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| 49 | 2021-02-07 | pain |
After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave...
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After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave water and observed for 40 minutes. Oxygen was 98-100% HR 70-78 BP 146-150/96-100s. Symptoms lasted around 1 hour. After arriving home BP was 110/78. Patient felt better. No hospitalization needed. Next day patient felt Body aches, Head ache, fever last 20 hours. Patient feels better today 2/8/2020 the only symptom left is fatigue.
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| 49 | 2021-02-07 | facial paralysis |
Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old fema...
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Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-10 | dizziness |
First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn'...
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First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn's flare with abdominal pain and diarrhea, which has continued. Hospitalized due to dehydrating and low potassium, given steroids, fluids, and potassium supplement.
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| 49 | 2021-02-16 | dizziness, numbness |
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver...
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About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
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| 49 | 2021-02-19 | vertigo |
I am not sure if this is related or not, but 15 days after my 2nd Pfizer dose I started having Vert...
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I am not sure if this is related or not, but 15 days after my 2nd Pfizer dose I started having Vertigo. I continue to have vertigo. I saw my doctor on January 27 and we tried steroids, lorazepam, and phenergan. I saw a physical therapist for vertigo and continue to do exercises to treat vertigo. I did have a previous incidence of vertigo a couple weeks after a flu vaccine about 3 years ago. I just wanted to report my symptoms as the Covid vaccine is new. I have currently not recovered from this episode of vertigo and cannot work at this time.
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| 49 | 2021-02-21 | facial paralysis |
Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey....
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Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey. Rx for prednisone.
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| 49 | 2021-02-21 | dizziness | Patient felt light headed. Denies SOPB, chest pain, palpitations, V/V, or visual changes. |
| 49 | 2021-02-21 | pain in extremity, tingling |
RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WI...
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RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WITH COMPLAINT OF LEFT ARM PAIN (TINGLING, HEAVY SENSATION). DIAGNOSED WITH PARESTHESIA OF LEFT UPPER EXTREMITY, GOITER, AND DEGENERATIVE DISC DISEASE. DISCHARGED TO HOME SELF CARE.
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| 49 | 2021-02-22 | pain, pain in extremity |
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S...
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Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
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| 49 | 2021-02-22 | tremor | Tremors in arm afterward |
| 49 | 2021-02-28 | pain in extremity |
2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil...
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2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was "very sore". "she was glad that she was close to home when this happened. It was kind of freaked her out." Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts." No lab work was done. No treatment was received for the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 49 | 2021-02-28 | pain in extremity |
arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old fe...
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arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EK9231), intramuscular at the left upper arm on 05Jan2021 10:20 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 05Jan2021, the patient experienced arm pain/soreness she took some Tylenol, not that she needed too much. She recovered from the arm pain/soreness within a day or two days. It was not a big deal. The patient weight was 157-158lbs on an unspecified date. The outcome of the event was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-02-28 | migraine, pain in extremity |
dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; t...
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dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization). The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, "turn off the lights in the office/has to have the lights low, still sensitive", and "dull achiness on the right side of temple area/headaches". The patient had not recovered from really bad migraine, head was sensitive, and "dull achiness on the right side of temple area/headaches". The outcome of the events "turn off the lights in the office/has to have the lights low, still sensitive" and arm hurt worse with second dose was unknown.
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| 49 | 2021-03-03 | balance disorder, pain |
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appet...
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Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
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| 49 | 2021-03-04 | bell's palsy, tingling |
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ...
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She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
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| 49 | 2021-03-07 | bell's palsy | Bells Palsy |
| 49 | 2021-03-07 | dizziness, pain |
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a...
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Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
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| 49 | 2021-03-08 | tingling, numbness |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-12 | tingling, pain in extremity, feeling hot |
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist...
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Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
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| 49 | 2021-03-13 | dizziness, numbness |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 49 | 2021-03-14 | lethargy |
Patient has MS and UC - weeks of lethargy; Patient has MS and UC - weeks of lethargy; lethargy; This...
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Patient has MS and UC - weeks of lethargy; Patient has MS and UC - weeks of lethargy; lethargy; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Feb2021 01:00 PM at single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant. Patient has MS (multiple sclerosis) and UC (ulcerative colitis) - weeks of lethargy on Feb2021. AE resulted in doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The patient underwent lab tests and procedures which included SARS-CoV-2 test: COVID yes prior vaccination. Events outcome was recovering. Information about lot/batch number has been requested.
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| 49 | 2021-03-22 | pain | Fever, chills, nausea, vomiting, severe headache, neck and body pain |
| 50 | 2020-12-31 | dizziness |
I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was...
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I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was driving home and did become itchy and developed a couple of small hives that quickly went away. The main event that I am reporting is a severe outbreak of eczema. I used to get it on my hands as a child and it was caused by citrus. On the morning of 12/24, I noticed itching and a red rash starting on my right wrist and my left hand. I thought perhaps it was from over washing or not rinsing all of the soap off. The rash became worse and I noticed a small area above my lip on the left side, I then developed a large area on the right side of my lower face. There were also a few spots elsewhere but these were the worst.
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| 50 | 2021-01-01 | dizziness |
Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my ...
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Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my primary care office next week Dec 28th, MD confirmed it was swollen lymph node likely related to immune response to COVID vaccine.
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| 50 | 2021-01-02 | pain in extremity |
Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffnes...
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Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffness also noted. The worse pain on left arm felt on first day, then slowly got better after. However still with Limited mobility (my left arm movement very guarded due to feeling of soreness on the affected arm), stiffness on left arm. Ice pack, advil and tylenol, and sometime with cyclobenzaprine, which I thought would help, but did not help.
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| 50 | 2021-01-03 | pain in extremity |
After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was e...
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After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit
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| 50 | 2021-01-03 | pain | Chills Headache Body Aches No fever |
| 50 | 2021-01-03 | pain | Constant and severe Pain from injection site traveling all the way up my arm and into my neck. |
| 50 | 2021-01-03 | pain in extremity, pain |
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortne...
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Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache
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| 50 | 2021-01-03 | feeling cold, dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
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| 50 | 2021-01-03 | dizziness |
dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. ...
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dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. Vitals monitored, were normal, sent home and advised to take Benadryl. More hives on upper lip/chin appeared 36 hours after vaccine given. Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.
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| 50 | 2021-01-03 | dizziness | dizziness, palpitations and lightheadedness right after vaccination and lasted up to 2 hours |
| 50 | 2021-01-04 | feeling hot |
5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL A...
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5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL AND DISCHARGED TO HOME STABLE. EMPLOYEE REPORTS HER HR INCREASED THAT NIGHT AND NEXT DAY FOR A FEW MINUTES AND THEN COMPLETELY RESOLVED BY THE THIRD DAY.
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| 50 | 2021-01-04 | dizziness |
Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and...
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Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness. She was given benadryl and pepcid, monitored for 3hrs before discharge from ED. Patient still experiencing same symptoms 1 week later per follow-up (12/29)
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| 50 | 2021-01-04 | pain |
Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, b...
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Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), Intramuscular on 22Dec2020 17:45 at single dose for covid-19 immunisation. Vaccine administered in left arm. Medical history included Anemia and Hypothyroidism. Patient is not pregnant. Concomitant medication was not reported. Patient had allergies to Levaquin. The patient experienced extreme fatigue, body aches, and headaches that began around day 4 post vaccine on 26Dec2020. Patient has not been tested for coronavirus disease (COVID-19). Patient was not diagnosed with COVID-19. Outcome of events was not recovered.
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| 50 | 2021-01-04 | pain | Fever 100.3 Body aches Trouble breathing Chills Headache |
| 50 | 2021-01-04 | migraine, pain |
Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Naus...
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Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Nausea; This is a spontaneous report from a contactable Registered nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: E10140), via an unspecified route of administration on 23Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included ongoing Diabetic for at least 7 years, ongoing hit in the head (She was a psych nurse and was hit in the head at work maybe a month to two months ago in 2020. She did have headaches from that incident). There were no concomitant medications. The patient experienced headache on 23Dec2020, fever on 24Dec2020 14:30, nausea on 23Dec2020, cough on 24Dec2020, really lazy on 24Dec2020, chills on 24Dec2020 14:30, body aches on 24Dec2020, sometimes her headaches were migraines on an unspecified date. Specifically, it was reported that when she first got the vaccine, she didn't have anything but a headache and a little bit of nausea. She had worked the night before and didn't sleep before the shot. So maybe that had a part in it. She was a diabetic. It was fine, and no big deal that night. Then, the next day on 24Dec2020 at 2:30 pm she woke up and she was freezing and couldn't get warm. She had chills and a fever of 102.1 on 24Dec2020. She took Tylenol, and it came down to 101 on an unspecified date in Dec2020. All weekend long, she has had a fever. It has been controlled by Tylenol. She had chills so bad she had to use her heated blanket. She has had a cough. She has been really lazy. She has had chills and body aches. She has had nausea here and there. She has had a headache. She received the vaccine on the 23Dec2020, which was Wednesday. She had to stay 15 minutes after. That is when she developed the headache and nausea. Sometimes her headaches were migraines. She developed the fever on 24Dec2020 14:30. Or noticed the fever when she woke up. Her fever was 101.2 this morning on 28Dec2020. Within the 15 minutes of getting the vaccine, she developed the nausea. It has gotten better. Her body aches are getting better. She still has chills when she is running a fever. She has gotten better overall. Thursday (24Dec2020), Friday (25Dec2020), and Saturday (26Dec2020) it was awful. Sunday (27Dec2020) the symptoms lightened up. Today (28Dec2020) she was better. She still had a headache and fever this morning, but nothing like she had been feeling. She felt like dying those days. She was a Psych nurse, and she got hit in the head. So she did get headaches from that incident. They are about the same as these headaches so she didn't know if it was related. It just went along with the flu like symptoms. But sometimes these headaches were migraines. Therapeutic measures were taken as a result of fever and chills. The outcome of the events headache, chills was not recovered. The outcome of the event really lazy was recovered on 27Dec2020. The outcome of the events fever, nausea, cough, body aches was recovering. The outcome of the event migraines was unknown.
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| 50 | 2021-01-04 | pain in extremity | The patient reported ankle, leg and hip pain for which she is taking Motrin |
| 50 | 2021-01-04 | weakness |
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l...
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allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
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| 50 | 2021-01-04 | pain |
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex...
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body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
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| 50 | 2021-01-04 | dizziness |
diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bi...
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diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
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| 50 | 2021-01-04 | dizziness, feeling of body temperature change, pain in extremity |
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som...
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headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
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| 50 | 2021-01-04 | numbness | left sided numbness |
| 50 | 2021-01-04 | pain, pain in extremity |
underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting he...
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underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
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| 50 | 2021-01-05 | dizziness | Dizziness, Elevated |
| 50 | 2021-01-05 | tingling, numbness |
Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/20...
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Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/2020. Employee states she cannot turn key in door or use right arm and hand normally. Employee reports parasthesias including slight numbness and tingling. Employee reports pain that is in the back of her shoulder that is rated as 2-3/10. Employee states all of her symptoms have been the same since 12/30 and have not worsened and no new symptoms had started.
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| 50 | 2021-01-05 | pain in extremity |
Had welt at injection site the size of golf ball with redness spreading from site out about the size...
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Had welt at injection site the size of golf ball with redness spreading from site out about the size of a baseball. Site itched, redness with heat coming out of site for several days. Arm soreness for 5-6 days afterwards. Injection give on 12/22/2020 and today 1/6/2021 there still is soreness at injection site and slight redness of the area.
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| 50 | 2021-01-05 | dizziness |
Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light head...
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Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light headed, felt like head and tongue were swollen, but they didn't appear to be swollen. Speech was clear. Treated with 25mg benadryl po and monitored for 45 minutes and patient stated symptoms resolved.
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| 50 | 2021-01-05 | tingling | Pfizer-BioNTech COVID-19 Vaccine EUA left arm and leg persistent paresthesias for two weeks |
| 50 | 2021-01-05 | tingling, pain |
Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened ...
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Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.
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| 50 | 2021-01-05 | tremor |
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began...
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Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
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| 50 | 2021-01-05 | balance disorder, dizziness, weakness |
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115...
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Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-05 | tingling |
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w...
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swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
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| 50 | 2021-01-06 | pain | CHILLS, FULL BODY SKELETAL ACHES AND FEVER |
| 50 | 2021-01-06 | lethargy |
Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stingin...
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Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy
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| 50 | 2021-01-06 | pain | Fatigue, body aches, headache x 3 days now resolved. |
| 50 | 2021-01-06 | pain in extremity |
Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 he...
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Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 headache still present but improve. Arm is mildly sore - much better
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| 50 | 2021-01-06 | lethargy | Lethargy/fatigue, mild headache (off and on) since approx. 5.5 hrs after vaccine. |
| 50 | 2021-01-06 | pain, migraine |
MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN A...
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MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.
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| 50 | 2021-01-06 | pain | Nausea, Chills, Achiness, pain from head to toes |
| 50 | 2021-01-06 | tingling, numbness, dizziness |
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive ...
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Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
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| 50 | 2021-01-06 | balance disorder, dizziness |
PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, B...
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PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, BP 142/91
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| 50 | 2021-01-06 | pain |
Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning aft...
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Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
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| 50 | 2021-01-06 | pain |
Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning aft...
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Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
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| 50 | 2021-01-06 | dizziness, lightheadedness |
Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 08...
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Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 0834 by LVN. RN informed front desk to call rapid response at 0835. Pt transferred from waiting area to wheel chair then to gurney 0836 vs: bp:151/109 hr:95 02sat: 90 room air- complaint of dizziness, feeling like she is going to pass out, headache 6/10, diaphoretic hands bilaterally, tearful, feeling like she is going to pass out, complaint of congestion, notes she has history of htn and sleep apnea, pt states that she was not feeling well since administration of vaccination however did not inform LVN. 0837:2L o2 via nasal canula 0840: vs: BP 138/75 hr:83 02 sat:94 97.7 temp: on 2L nasal cannula, rapid response arrived report given, pt still feeling the same. 0845: vs bp: 133/84 hr: 79 o2sat: 94 0850: rapid response nurse cleared pt to be discharged, pt given option of going to ED for observation however declined at the time. 0851: pt sat up repeat o2sat: 95 on room air- states that she is feeling better, stating "I think I just have to go home and take a nap" 0855: pt requesting to be discharged, encouraged to have someone drive her home states she will call her sister- pt never picked up phone to call sister- then insisted she is fine to dive herself home. 0856: cleared with -supervisor that pt okay to be wheeled down to car by LVN be wheeled down to car- pt given ed precautions. 0907: LVN reported that pt elected to go to ED as she was experiencing dizziness per LVN. In ED pt given IV Benadryl 25 mg, tordol 15mg iv, 1 liter Lactated ringers, 4 mg Zofran iv
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| 50 | 2021-01-06 | tingling, numbness, pain in extremity, feeling hot |
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf...
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The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
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| 50 | 2021-01-06 | tingling | tinnitus, face tingling, lymph pain, general muscle pain |
| 50 | 2021-01-06 | feeling hot |
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u...
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warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
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| 50 | 2021-01-07 | pain |
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Ty...
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01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
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| 50 | 2021-01-07 | feeling cold |
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were ...
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10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
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| 50 | 2021-01-07 | pain |
Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really...
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Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really tired/exhausted; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included Hashimoto's Goitre, migraine, Pacemaker, she just had her third one replaced, that was since I was 27. Concomitant medication included levothyroxine for Hashimoto's Goitre, sertraline, topiramate (TOPAMAX). The patient received the vaccine on 30Dec2020. She had congestion, she was still congested. That night on 30Dec2020 she was tired, just tired and exhausted and woke up Thursday on 31Dec2020, really tired. The patient had been really busy with work with everything, so, she just 'threw to the wind'. She was really tired on Thursday, 31st, just like, she really feel sick, coughing, really exhausted. she came home and just got to go to bed and 7 to 3:30. She felt warm but she didn't get hot and she took temp, she was 101.5. She had chills, a cough. She was so exhausted, everything hurts her. The patient don't feel like terrible, terrible, like mostly she would say Friday on 01Jan2021, she was mostly in bed. She just didn't want to just lay there. She thought that was worse laying there. She didn't know if I was positive with COVID in the middle of this, or was it the vaccine. About causality, the reporter stated that she didn't know, 50-50, it partly felt like she didn't know if she was having a reaction to the vaccine or she was positive for COVID or she was getting (incomplete sentence). She was congested and the all of a sudden, she didn't know if positive for this. She guessed if she get tested which she was assuming if she call or occupational health, they want her to get tested for COVID because she already have the symptoms. She didn't do anything yet for events. She had just been home and quarantined. Her brother who she have been around, he doesn't live with her but he lived down the street. He was in critical care right now in (state) and with COVID, so that's another concern, why she was thinking she could be COVID. The outcome of the events was unknown. Information for Lot/Batch number has been requested.
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| 50 | 2021-01-07 | dizziness |
Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear,...
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Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear, dizziness.
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| 50 | 2021-01-07 | weakness |
Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf ...
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Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf of his mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 31Dec2020 between 09:00 and 10:00 at single dose on left arm for covid-19 immunisation (works in food staff at a hospital). Medical history and concomitant medications were none. Patient experienced: difficulty breathing and weakness on 01Jan2021. Events were ongoing and had gotten a little worse today (05Jan2021). The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.
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| 50 | 2021-01-07 | restlessness |
Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she w...
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Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.
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| 50 | 2021-01-07 | weakness, dizziness, tingling |
Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body...
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Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body." She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.
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| 50 | 2021-01-07 | seizure |
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o...
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approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
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| 50 | 2021-01-07 | numbness, tingling |
decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain s...
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decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain starting on 12/24/20 which has gradually improved with only rare episodes of numbness as of today 1/8/20. No weakness, back pain or injury.
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| 50 | 2021-01-07 | dizziness |
dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives ...
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dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 50 | 2021-01-07 | lightheadedness | employee felt near syncope[al episode post vaccine administration |
| 50 | 2021-01-07 | weakness, pain in extremity |
headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the bod...
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headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.
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| 50 | 2021-01-07 | dizziness | inject site soreness, dizziness, headache, chills |
| 50 | 2021-01-07 | dizziness |
numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a...
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numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular on 22Dec2020 at single dose for Covid-19 immunisation. Patient was not pregnant. The patient medical history was not reported. Concomitant medication included meclizine, ondansetron (ZOFRAN), famotidine. The patient was admitted to emergency room (ER) post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness on 22Dec2020. She was given Benadryl and Pepcid, monitored for 3 hours before discharge from ER. Patient still experiencing same symptoms 1 week later per follow-up (29Dec2020). This case was reported as non-serious. The outcome of events was unknown.
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| 50 | 2021-01-07 | dizziness, tingling, numbness |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-07 | feeling hot |
sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness t...
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sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes
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| 50 | 2021-01-08 | weakness, pain |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-08 | migraine, dizziness |
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B...
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About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
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| 50 | 2021-01-08 | pain in extremity |
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left a...
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Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
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| 50 | 2021-01-08 | pain in extremity |
Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subseq...
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Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21
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| 50 | 2021-01-08 | tingling |
Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever...
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Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever, fatigue
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| 50 | 2021-01-08 | pain |
Right upper quadrant dull pain 4/10 around the liver area, has not checked liver enzymes Narrative: ...
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Right upper quadrant dull pain 4/10 around the liver area, has not checked liver enzymes Narrative: has not seeked medical care
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| 50 | 2021-01-08 | tingling, numbness | Tingling and a feeling of numbness to R side of face |
| 50 | 2021-01-09 | tenderness |
After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the ...
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After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the second dose the lump got bigger and it?s a little tender this time. It?s been two days since the 2nd injection and doesn?t seem to be going down in size.
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| 50 | 2021-01-09 | pain |
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start...
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Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
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| 50 | 2021-01-09 | weakness |
Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness ...
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Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.
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| 50 | 2021-01-09 | pain in extremity | Low grade fever, large hard painful lump in right arm, achy joints |
| 50 | 2021-01-09 | pain |
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,...
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STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
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| 50 | 2021-01-10 | pain | Chills Body aches Fatigue |
| 50 | 2021-01-10 | pain | Chills, body aches, slight headache |
| 50 | 2021-01-10 | dizziness, vertigo | Dizzy, Room Spinning, headache |
| 50 | 2021-01-10 | pain |
Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body...
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Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body ache, nausea, pain on the site of injection but mild compared to first dose, tiredness, fever from 9:00 am until bedtime on 01/08/2021
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| 50 | 2021-01-10 | pain | Fever 99.4-100.6 for 3 days after mild headache and body aches now resolved |
| 50 | 2021-01-10 | pain in extremity, pain |
First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but ...
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First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but my armpit was so painful (felt like stabbing sensation). This lasted until around 2:00 pm Saturday. I felt ok except for being tired and armpit still hurting quite a bit. On Sunday, I was very tired and slept during the day and went to bed around 8:30 pm feeling like I had a slight sore throat, tired and mildly nauseous. My armpit still hurt quite a bit. I woke up Monday at 5:30 am and showered and was profusely sweating when I was getting ready for work - my temperature was 100.6 so I took 800 mg of Ibuprofen to help with the temp and the pain in my armpit. I did not go into work. I am still tired and my current temp is 100.1 (12:30pm) and sweaty. I do feel as though the severity of my armpit pain is lessening but it is still bothersome.
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| 50 | 2021-01-10 | pain | body ache, fever, nausea. called in sick to work. |
| 50 | 2021-01-10 | pain |
fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness i...
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fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital
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| 50 | 2021-01-11 | tremor, tingling |
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig...
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30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
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| 50 | 2021-01-11 | weakness, pain, pain in extremity |
Approximately 11 hours after the vaccination my arm became very sore, to the point that it was diffi...
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Approximately 11 hours after the vaccination my arm became very sore, to the point that it was difficult to lift it. I then developed body aches and chills. I did not develop a fever that I know of but the body aches and chills continues throughout the night. During the night a severe headache developed as well as generalized weakness. I was unable to sleep and had to miss work the next day. Because the weakness and body aches continue, I plan to miss a second day of work tomorrow. I treated the symptoms with Tylenol.
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| 50 | 2021-01-11 | migraine, pain, feeling cold | Chills, body aches, migraine, nausea. Improving |
| 50 | 2021-01-11 | pain |
Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of sympto...
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Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of symptoms Left axillary lymphadenopathy for approximately 3 days
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| 50 | 2021-01-11 | pain, weakness |
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU...
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GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
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| 50 | 2021-01-11 | pain | Headache, Body aches, Low grade Fever, Fatigue |
| 50 | 2021-01-11 | difficulty speaking |
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PAR...
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INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
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| 50 | 2021-01-11 | pain in extremity, facial paralysis, dizziness, bell's palsy |
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m...
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Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms. Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
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| 50 | 2021-01-11 | tingling |
Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of rece...
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Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of receiving the COVID vaccine. Fifty mg of liquid diphenhydramine was administered & the patient was monitored for another 45 minutes. She reported her symptoms slowly improved over time. No throat or tongue swelling was reported at any time.
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| 50 | 2021-01-11 | lightheadedness, dizziness | Received 1st dose vaccine and became nauseated, dizzy, lightheaded and almost passed out. |
| 50 | 2021-01-11 | tremor |
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject...
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Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
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| 50 | 2021-01-11 | balance disorder, numbness, tingling |
Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensif...
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Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia
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| 50 | 2021-01-11 | pain |
Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area when...
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Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area whenever I took a deep breath. No other symptoms. No fever no real shortness of breath only when inhaling deep and exhaling. Continued as a dull ache in the background. I was due for my 2nd covid vaccine which I proceeded to get at 1045am on 1/9/2021. The pain continued as a dull ache in the background. I took Ibuprofen 600mg and then later took a Pepcid 20mg. No real change with the pain and by 3:30pm in the afternoon it was starting to get worse so I when to ER. All tests were normal, I was diagnosed with Pleurisy but no cause was identified. Have taken Aleve 2 x a day for 3 days and tylenol as needed. I self scheduled a covid test 1/11/2021 which was negative. on 1/12/2021 I still have mild pain but it has slowly improved but has not resolved as of this date 1/12/21 Still no other symptoms.
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| 50 | 2021-01-11 | feeling hot |
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ...
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both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
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| 50 | 2021-01-11 | feeling of body temperature change, pain in extremity, pain |
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa...
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not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
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| 50 | 2021-01-11 | pain |
woke up in the middle of the night with fever and chills, had headaches and body aches for 3 days af...
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woke up in the middle of the night with fever and chills, had headaches and body aches for 3 days after
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| 50 | 2021-01-12 | pain |
1/9-had body aches and fatigue. ibuprofen helped. 1/10-fatigue 1/11-fatigue stuffy nose. headache. 1...
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1/9-had body aches and fatigue. ibuprofen helped. 1/10-fatigue 1/11-fatigue stuffy nose. headache. 1/12-fatigue, runny nose, headache, diminished taste and smell 1/13 -fatigue, runny nose, headache, diminished taste and smell -PCR tested today.
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| 50 | 2021-01-12 | pain | 14 hours after dose symptoms as follows. Nauseous, fever and body aches lasting 24 hours. |
| 50 | 2021-01-12 | pain |
30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F). Fol...
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30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F). Following the first injection in the series I experienced very mild body aches and minor fatigue, also noted at approx 30 hours post-injection. Symptoms following the second injection were much more intense, included a fever and headache, and lasted longer (12-13 hours). Symptoms experienced following the second injection caused a missed work day.
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| 50 | 2021-01-12 | pain | Fatigue, body aches, chills. |
| 50 | 2021-01-12 | dizziness |
My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitati...
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My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-12 | pain | Pain at injection site, extreme fatigue, general body ache, temperature 102 F |
| 50 | 2021-01-12 | pain in extremity, pain, tingling |
Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm sh...
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Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm shoulders pain body aches and fever
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| 50 | 2021-01-12 | dizziness | Patient felt intense dizziness with nausea for three hours before symptoms resolved. |
| 50 | 2021-01-12 | feeling hot |
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi...
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Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
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| 50 | 2021-01-13 | pain |
1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues pre...
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1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues presently. Woke up 1/9/2021 @0400 with headache & severe body aches & chills lasted 2hr Currently: body aches, chills, exhaustion (these symptoms come & go since 2nd injection)
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| 50 | 2021-01-13 | pain |
102.6 fever; headache; body ache treated with tylenol fever went down to 100.9 with Tylenol and brok...
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102.6 fever; headache; body ache treated with tylenol fever went down to 100.9 with Tylenol and broke at 3:30 pm (approx 12 hours after onset)
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| 50 | 2021-01-13 | dizziness, dizziness |
Adminsitration of vaccine at 8:40am; At 8:53; experienced dizziness and diaphoresis. Placed in supi...
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Adminsitration of vaccine at 8:40am; At 8:53; experienced dizziness and diaphoresis. Placed in supine position and provided a wet cloth for her forehead. Vital signs and blood pressure remained stable. She was provided a snack and discharged home.
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| 50 | 2021-01-13 | migraine |
Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontan...
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Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had the vaccine at her work and like in the night, in the morning, she started experiencing side effects. She was having like chills and muscle pain and she called her doctor and they told her that she had to report the side effects. She felt like real tired and she was having a headache. The patient took some Excedrin for headache, it's like migraine. She took two in the morning at 8:30. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-01-13 | pain, dizziness, weakness, pain in extremity |
Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain rad...
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Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain radiating to (L) elbow/(L) leg pain/dizziness/diaphoresis weakness to (L) lower extremity.
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| 50 | 2021-01-13 | pain |
Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactab...
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Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EKS730 and expiration date not provided), via an unspecified route of administration in the right arm on 05Jan2021 09:30 at a single dose for COVID-19 immunization. The patient has no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 02:00, the patient experienced fever of 102, body aches, chills, confusion, and headache. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
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| 50 | 2021-01-13 | pain in extremity |
It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spon...
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It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EL1284) via an unspecified route of administration on the left arm on 23Dec2020 17:20 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and was still experiencing soreness in her arm for more than 2 weeks. She wanted to know if she should get the second dose. She also wanted to know if she does get the second dose can she ask for a different needle size and different injection site. She had soreness in her arm on 24Dec2020 and if it was related to the COVID Vaccine. The soreness in her arm is in the left arm where the site of injection was. She noticed when woke up like am in the morning. She had an X-Ray done yesterday 06Jan2021 and it did not show any type of dislocation or fracture. She stated she knew the soreness in the arm was most commonly seen 48 hours after getting the injection, the COVID shot, she knew this was a normal side effect. However, she was wondering why she is still experiencing this and it's going on 2.5 weeks now. She later clarified when speaking to previous agent they were providing the number to speak to someone more about the side effects and questions. She wanted to know why she was having it more than 2.5 weeks after getting it. She has read literature and she saw there where it can occur, but it indicated it would not be more than 72 hours. She was worried about this. It was causing a decrease in mobility and effecting her mobility. There was no history of all immunizations with the Pfizer Vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to the emergency room or physician office. Outcome of the event soreness in her arm was not recovered, while unknown for the other event.
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| 50 | 2021-01-13 | numbness |
Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports sa...
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Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports same symptoms after first dose of Pfizer and lasted ~ 4 days after. Observed x 30 minutes. BP 128/80 HR 71 sat 100%
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| 50 | 2021-01-13 | pain, tremor |
Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdo...
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Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdominal pain.
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| 50 | 2021-01-13 | feeling hot, pain | Swollen lymph node warmth area fever pain |
| 50 | 2021-01-13 | pain | body aches, nausea |
| 50 | 2021-01-14 | pain, weakness, swollen extremities |
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes...
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1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
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| 50 | 2021-01-14 | dizziness |
1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 ...
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1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 88-96%RA; 1345-EE to ED room 14 for further evaluation.
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| 50 | 2021-01-14 | pain in extremity |
Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable co...
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Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.
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| 50 | 2021-01-14 | dizziness, feeling hot |
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ...
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Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
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| 50 | 2021-01-14 | dizziness, vertigo |
Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Verti...
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Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Vertigo; This is a spontaneous report from a contactable pharmacist. A 50-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscular at arm right on 17Dec2020 13:30 at single dose for COVID-19 immunization at a Workplace clinic. The patient's medical history was reported as none. No known drug allergies. Concomitant medication (received within 2 weeks of vaccination) included ergocalciferol (VIT D). The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that while getting first dose, patient experienced instant "funky lightheadedness, vertigo. Normal tinnitus got louder and oscillating up and down. Next day after first dose (18Dec2020), patient had sinus headache and vertigo, took meclizine and went back to bed. Felt fine when she woke up. The outcome of the events sinus headache and vertigo was recovered on an unspecified date, for the rest of events was unknown. The reporter consider the evens as non-serious.
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| 50 | 2021-01-14 | numbness, tingling, facial paralysis |
HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED...
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HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED LEFT SIDE OF THE FACE, NUMBNESS LIKE I WAS GIVEN LOCAL TO THE LEFT SIDE OF MY FACE. COULD BARELY FEEL MY FACE ONLY LEFT SIDE. FELT I WAS DROOPING. TEETH WAS TINGLING. MY LEFT ARM GOT BETTER IN 2 HOURS. THERE WAS NO WEAKNESS. HOWEVER MY LEFT SIDE OF THE FACE WAS NUMB AND TINGLING LASTED APPROXIMATELY 2 DAYS. INTENSITY OF THE NUMBNESS GOT BETTER BY THE EVENING OF THE SHOT. I TOOK 325 MG OF ASPIRIN WITHIN 15 MIN OF THE EPISODE . MY PULSE, BP AND OTHER VITALS NORMAL. MAIN WAS MY LEFT SIDE OF THE FACE .
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| 50 | 2021-01-14 | tingling |
I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring ...
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I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring fingers. I Thought that I had slept in my hand wrong.; The discomfort at injection site woke me again last night and had the same feeling. It has remained after waking this morning; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 7530) solution for injection, via an unspecified route of administration on right arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies to food, medications, or other products. The patient was not pregnant. Patient had the first dose of BNT162B2 on 18Dec2020 (lot number: EK 7530). Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), and melatonin at 1.5 mg, daily. The patient reported that on 09Jan2021, she woke about 3 am and had paresthesia of her fingers on her right hand, thumb, index, middle and ring fingers. She thought that she had slept in her hand wrong. The discomfort at injection site woke her again last night (09Jan2021) and had the same feeling. It has remained after waking this morning. No treatment was given. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.
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| 50 | 2021-01-14 | tingling |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-14 | pain |
diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a sp...
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diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EH9899), intramuscular in the left arm from on 16Dec2020 20:00 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, thyroid nodule, and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 20:00, 24 hours after receiving the first dose of BNT162B2 the patient experienced chills, body aches, malaise, headache and sore throat. On 18Dec2020 20:00, 48 hours after receiving the first dose of BNT162B2 the patient experienced diarrhea, nausea and loss of appetite. The patient was treated for the chills, body aches/malaise, headache and sore throat, diarrhea, nausea and loss of appetite with ibuprofen (Manufacturer Unknown). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, chills, body aches/malaise, headache, sore throat, diarrhea, nausea and loss of appetite, were all recovered on an unknown date. No follow-up attempts possible. No further information is expected.
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| 50 | 2021-01-14 | weakness, pain in extremity |
feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; wea...
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feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown. The outcome of events of severe headache, weak was not recovered. Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions. Potential
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| 50 | 2021-01-14 | dizziness |
funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This ...
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funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FK4176), intramuscularly on 07Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 13:30 on the right arm for COVID-19 immunization and experienced funky lightheadedness, vertigo, normal tinnitus got louder and oscillating up and down, and sinus headache. Concomitant medication included colecalciferol (VITAMIN D). On 07Jan2021 at 13:30 (as reported), patient experienced funky lightheadedness, weird feelings in head, and tinnitus was noticeably oscillated up and down. The events were assessed as non-serious. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on 07Jan2021 at 15:30.
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| 50 | 2021-01-15 | pain | Body aches for 24 hours. Itching and welts in areas 42 hours after injection. |
| 50 | 2021-01-15 | restlessness, vertigo |
I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 1...
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I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs. The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes. I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
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| 50 | 2021-01-15 | pain in extremity, pain, tenderness |
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, ...
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Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
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| 50 | 2021-01-17 | tingling |
I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I fe...
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I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
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| 50 | 2021-01-17 | pain, pain in extremity |
I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a...
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I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder. The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date. Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature. Outcome was not recovered. No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable. About causality, nurse stated Yeah, most definitely.
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| 50 | 2021-01-19 | pain |
2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue...
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2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue and swelling in her hands and ankles. Symptoms were significant until 1/11/21 but have been improving.
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| 50 | 2021-01-19 | weakness | Chills fever muscle cramps weakness headache |
| 50 | 2021-01-19 | pain | Fever, headache, chills, dry throat, body aches |
| 50 | 2021-01-19 | dizziness | Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site |
| 50 | 2021-01-19 | pain |
Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of inj...
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Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of injection. All accompanied by the usual fever, body, and joint aches which subsided at 48 hours after injection. Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling still present.
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| 50 | 2021-01-19 | dizziness | anxious, light headed |
| 50 | 2021-01-21 | dizziness, feeling cold |
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu...
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Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
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| 50 | 2021-01-21 | pain | Headache, diarrhea, body aches |
| 50 | 2021-01-21 | dizziness |
I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt...
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I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt very fatigued and fell asleep. At about 11pm I experienced tachycardia that lasted one week with some palpations for another week. My hear rate was over 100. On 12-30-20 my heart rate was not coming down, so i called my nurse cardiologist and he gave me a a refill Metoprolol 6.2mg for me to take this medication only if my heart rate was over 100 to take as needed. I only took Metoprolol for one day. My PCP recommended an EKG. Today I still more fatigued than usual.
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| 50 | 2021-01-21 | dizziness |
I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fat...
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I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fatigued and fell asleep. then about 11:30pm i experienced tachycardia which lasted one week. My hear rate was over 100bpm. The next day on 12-30-20, my hear rate was not coming down and i spoke with my cardiologist nurse and she did a refill for Metoprolol 6.2mg. I was to only take it if my hart rate was over 100bpm.
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| 50 | 2021-01-21 | pain |
I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or f...
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I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or five days.
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| 50 | 2021-01-21 | dizziness | Patient became nauseous, diaphoretic, dizzy and felt as if she was going to "pass out" |
| 50 | 2021-01-21 | dizziness |
Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shi...
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Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shifts.
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| 50 | 2021-01-21 | tremor, numbness, tingling, seizure |
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu...
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Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
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| 50 | 2021-01-24 | lightheadedness, dizziness, numbness, tremor, tingling |
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes...
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1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
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| 50 | 2021-01-24 | pain | Pf,izer-biotech covid-19 vaccine eau Body aches, chills, fever |
| 50 | 2021-01-25 | tingling |
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including lef...
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About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
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| 50 | 2021-01-25 | tingling |
Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tin...
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Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tingling in arm". After waiting approximately 30 minutes after first report of tingling, patient stated tingling resolved with no other signs/symptoms.
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| 50 | 2021-01-25 | dizziness, pain, pain in extremity |
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;...
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Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 50 | 2021-01-25 | dizziness |
So it started with a cough on that Sunday and then the following day I woke up cold and dizzy and I ...
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So it started with a cough on that Sunday and then the following day I woke up cold and dizzy and I had a fever 100.3F I developed Monday excruciating headache and it was difficult to see. The fever and headache lasted for about 2 days and I developed a cough again and it lasted a couple of days. Fatigue lasted for about 12-14 days. I was tested for COVID on Monday 12/28 and results came back positive on 12/29
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| 50 | 2021-01-25 | dizziness |
This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient'...
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This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient's son). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER5730, Expiry Date: Mar2021), via an unspecified route of administration on 22Dec2020 at a single dose on Left Deltoid for COVID-19 immunization. Medical history included asthma and sickle cell disease. There were no concomitant medications. She has had issues with vaccines in the past but not to this extent. Prior she experienced swelling in the arm from a pneumonia vaccination for immunization, back in 2012, she has no Lot or Expiry of this previous vaccine. She adds that she did feel dizzy after the first vaccine dose but that subsided. She has had no positive tests for COVID, and no antibody tests. The outcome of the event was recovered on an unspecified date.
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| 50 | 2021-01-25 | pain |
chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneo...
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chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el0142) intramuscularly at left arm on 11Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included herniated disk L5 S1. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C), vitamin b complex (VITAMIN B), cefixime (FLEXERIL), calcium, magnesium, curcuma longa (TURMERIC). The patient previously received first dose of bnt162b2 (lot number: ek5730) intramuscularly at left arm on 21Dec2020 15:45 at single dose for COVID-19 immunization. The patient experienced chills, severe all over body aches especially left arm, headache, sleeplessness, on 11Jan2021 23:30. No treatment received. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
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| 50 | 2021-01-25 | feeling of body temperature change |
headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous r...
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headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 06Jan2021 09:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 (09:00 AM) for Covid-19 immunization. Medical history included hypothyroidism; no known allergies. Concomitant medications included levothyroxine, macrogol 3350 (MIRALAX), docusate sodium (COLACE), and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM FOR WOMEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that it was the second dose of her Pfizer COVID vaccine series; 12 hours afterwards she got shaking chills and nausea (06Jan2021) and this continued overnight, no fever. The next morning, she had the worst headache of her life, and nausea and alternating feeling hot and cold, no more shaking chills and no fever. The patient reported that it continued throughout 07Jan2021, and on 07Jan2021 she vomited once. Then 08Jan2021 in the morning, she still had the worst headache of her life, she took Ibuprofen to which the headache became much diminished. But headache continued with less intensity, so she was able to go to work throughout 08Jan2021. She continued with Ibuprofen and added Tylenol. Then at 3 am on 09Jan2021, she woke with the worst headache again so severe and took both Ibuprofen and Tylenol and it got better. By afternoon 09Jan2021, she was back to herself with no more headache and a normal appetite. She did take a sick day on 07Jan2021. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 post vaccination.
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| 50 | 2021-01-26 | dizziness, pain, feeling hot |
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard...
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1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
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| 50 | 2021-01-26 | pain in extremity, numbness |
After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down ...
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After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down to my finger tip that caused numbness of my fingers, I could not move my arm due to pain, I was not even able to roll over and sleep on it because the pain was so intense. The severe pain lasted about 2 days and my arm was sore for about a full week after.
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| 50 | 2021-01-26 | pain in extremity, pain |
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa...
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Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
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| 50 | 2021-01-26 | dizziness |
BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mi...
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BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mid chest pressure. Not radiating pain and some dizziness. No blurred vision, no nausea. Patient was placed supine and monitored for an elevated blood pressure. first BP was 180/110. HR was 101. Sat at 94% on room air. Had med history of cancer and other conditions. Normal VP baseline is usually low. Vital s taken before 2 EMTs and on-scene doctor. Patient recovered.
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| 50 | 2021-01-26 | pain | Fever of 101. Very bad headache & all over body aches. |
| 50 | 2021-01-26 | pain, dizziness | Fever, Body aches, Dizziness, |
| 50 | 2021-01-26 | pain | Headache, fever, body aches, sore throat, fatigue |
| 50 | 2021-01-26 | migraine |
Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex l...
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Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex lasted 2hours both relieved with imitrex
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| 50 | 2021-01-26 | pain in extremity, pain |
Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with red...
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Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with reduced range of motion and use in right arm. This started about 2-3 days after vaccine administration. I had no difficulty with right arm before vaccine.
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| 50 | 2021-01-26 | weakness |
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;...
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Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-26 | pain |
With the second dose I ended up with severe pain on my upper back through my neck/shoulder area and ...
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With the second dose I ended up with severe pain on my upper back through my neck/shoulder area and also had pain in my rib cages (both). I experienced joint pain in my ankles and knees (no known case of arthritis) they were off and on and extreme fatigue. I still have pain in my upper back/neck shoulder area and the fatigue. The rib cage pain and the joint pain are gone
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| 50 | 2021-01-26 | feeling cold, pain, tremor, weakness |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | tingling |
itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Satur...
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itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Saturday evening 1/23
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| 50 | 2021-01-26 | dizziness | lightheadness, dizziness, & hypotension |
| 50 | 2021-01-26 | pain in extremity |
pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache...
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pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache nausea diarrhea
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| 50 | 2021-01-26 | pain | soreness to injection site, mild headache, mild bodyache |
| 50 | 2021-01-27 | unresponsive to stimuli |
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t...
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Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
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| 50 | 2021-01-28 | feeling cold |
10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient star...
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10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.
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| 50 | 2021-01-28 | dizziness |
Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non...
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Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non-contactable Other Healthcare Professional (HCP, also the patient). A 50-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration on 16Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient's concomitant medications were not reported. The patient didn't have other vaccines in four weeks. The patient didn't have COVID prior vaccination. The patient experienced fever, muscle pain, joint pain, headache, nausea and dizziness on 17Jan2021 04:00 AM . No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination. Information on lot/batch number has been requested.
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| 50 | 2021-01-28 | pain in extremity |
Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like ...
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Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like a spasm; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old female patient received BNT162B2 (lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:04 at single dose for COVID prophylaxis. There were medical history and concomitant medications. It was reported that the patient experienced leg pain, back pain and lips twitching after injection which occurred two days ago on 13Jan2021. Stated that leg pain is like Achilles tendon pain in her left leg and back pain is almost like a spasm. She doesn't know if this is an expected side effect. Second dose is scheduled 09Feb2021. She wants to know if she should proceed with that. The outcome of the event "lips twitching" was unknown wile for the other events was recovering. The reporter assessed the events to be related to the suspect vaccine.
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| 50 | 2021-01-28 | weakness, dizziness | feeling weak, dizzy, light headed and intense headache |
| 50 | 2021-01-31 | pain |
1/28/21 at 11pm I began feeling overall unwell so I checked my temperature orally as soon as feasibl...
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1/28/21 at 11pm I began feeling overall unwell so I checked my temperature orally as soon as feasible, as I had been traveling on airplane, and I noted fever developing. Overnight I experienced increasing fever and chills, noting fever arriving and staying at 102.4 by middle of the night/very early on 1/29/21. Experienced intense headache and whole body aches. On the morning of 1/29/21 when I got out of bed I felt nauseated and vomited. I still had fever of 102, chills, intense headache and whole body aches. I went back to bed and stayed there until the morning of 1/30/21 continuing to experience all the same symptoms. By 8pm on 1/29/21, I needed relief so I took 500mg acetaminophen. I took 500mg acetaminophen again at 1am and again at 9am on 1/30/21. When I got out of bed the morning of 1/30/21 I noted I still had fever but it was lower at 100.4. On 1/31/21 fever has gone but headache, fatigue and body aches with general feeling of not feeling well.
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| 50 | 2021-02-01 | facial paralysis |
Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower...
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Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested.
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| 50 | 2021-02-01 | facial paralysis |
Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfiz...
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Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfizer vaccine (1/5/21 vaccine given). Not sure what the recommendation is as to whether I should still have the second dose. Doctors at the ER were not sure either.
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| 50 | 2021-02-01 | numbness |
[ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing ...
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[ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing in hand of injection site on day of injection of dose one then experience numbing again three weeks later (before the second dose).
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| 50 | 2021-02-10 | facial paralysis |
Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a conta...
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Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-02-10 | lightheadedness |
felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100;...
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felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-14 | pain, lethargy |
Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a...
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Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:30 in right arm, at single dose for covid-19 immunization. Medical history included allergy to adhesive tape. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included flecainide. The patient previously took morphine, demerol, codeine, dilaudid and allergies to morphine,demerol, codiene, dilaudid, golytle (as reported). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The patient experienced severe headache on 24Dec2020 04:00, lethargy on 25Dec2020, severe body aches on 26Dec2020, high fevers on 27Dec2020, covid 19 nasal swab: positive on 28Dec2020. Seriousness criteria was reported as disabling/incapacitating. Event result in clinic visit. Treatment antibiotics and prednisone was for Covid respiratory infection. The outcome of the all events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
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| 50 | 2021-02-14 | pain in extremity, nerve pain, tremor |
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain...
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Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-02-21 | pain |
Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (p...
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Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (patient) reported that a 50-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on left arm on 22Jan2021 17:00 at single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included eletriptan hydrobromide (RELPAX), atorvastatin (LIPITOR). The patient previously took first dose of BNT162B2 on 31Dec2020 at 05:00 PM for COVID-19 immunization. On 23Jan2021, patient had fever, body aches, headache and chills. The patient received treatment with TYLENOL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
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| 50 | 2021-02-21 | pain |
Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up...
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Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up at 0300 with severe joint pain, headache and chills. Nausea started shortly afterwards. The joint pain was excruciating and it was very difficult to move. By 0330, I started vomiting. Vomiting continued until approximately 0745. I felt dehydrated but was not able to hold down any water. I contacted the Nurse Advice line and spoke to a nurse. She asked me a series of questions, all relating to signs indicative of an allergic reaction. I knew I was not experiencing a typical allergic reaction. But I was experiencing a bad reaction. Based on my responses to her questions, she did not recommend that I go an Urgent Care Clinic or see a Doctor. The severe joint pain continued through 02/14/2021. I started to feel better on 02/15/2021. Even though I did not experience an allergic reaction, given the severity of my joint pain and vomiting, I still feel it is important for what I did experience to be documented. Thank you.
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| 50 | 2021-02-21 | dizziness, tingling |
Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling do...
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Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,
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| 50 | 2021-02-21 | dizziness, feeling of body temperature change, pain in extremity |
dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, ni...
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dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm
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| 50 | 2021-02-21 | pain in extremity |
sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a conta...
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sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 01Feb2021 15:15 (lot number: EL3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history includes ulcerative colitis, shellfish allergy, sulfa allergies unknown if ongoing from an unknown date. The patients historical drug included benzthiazide (REGULON) which caused allergies. Patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 14:15 in the left arm for COVID-19 immunization. Concomitant medications included tofacitinib citrate (XELJANZ) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D). The patient was administered with other vaccine on same day i.e. 01Feb2021. However, it was also reported that the patient did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm on 02Feb2021 05:00 AM. The patient did not received treatment. The consumer assessed the events as non-serious. The outcome of the sore arm was recovered in Feb2021. No follow-up attempts are possible. No further information is expected.
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| 50 | 2021-02-22 | tingling |
Arm burning from the inside out from injection site right after injection; headache; tingling hand a...
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Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-22 | feeling hot |
C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg ta...
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C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg tablet PO was given. BP taken.
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| 50 | 2021-02-22 | weakness, pain |
Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms...
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Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms included cough, rhinorrhea, sore throat, sinus congestion, severe headache, weakness, body aches, N/V/D, fever, chills, night sweats, abdominal pain. Was quarantined for 10 days post symptom onset.
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| 50 | 2021-02-22 | swollen extremities |
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl...
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Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
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| 50 | 2021-02-22 | numbness |
The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to cont...
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The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to control or move it. She could not grip the steering wheel or hold anything. She shook her hand and it returned to normal. At 10:15 itjhappened again. It happened a few more time while at work. She also had a few epidsodes in which her jaw became slack and off to the side and she had to close her mouth with her hand, because she could not control her jaw. The episodes lasted about 10 seconds and then they would disappear. She reported her symptoms to the us at about 12:30 PM, 2/23/2021.
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| 50 | 2021-02-23 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old...
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Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 50 years old) at a single dose for covid-19 immunization. Medical history included hypertension, gastrooesophageal reflux disease (GERD), obesity, and allergies: sulfa. Concomitant medications included hctz, escitalopram oxalate (LEXAPRO), losartan, metoprolol and omeprazole (PROTONIX [OMEPRAZOLE]). The patient is not pregnant. The patient had no other vaccine in four weeks and was not tested for covid post vaccination. On 09Feb2021, the patient experienced Bell's palsy. Therapeutic measures were taken as a result of the event Bell's palsy included prednisone and valacyclovir. Outcome of the event was not recovered.
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| 50 | 2021-02-23 | pain, pain in extremity |
Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from ...
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Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 18Dec2020 at 09:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included asthma, chronic back pain (surgery and scoliosis), migraines, systemic reaction to allergy injection, and COVID-19 in Jun2020 (prior vaccination). The patient's concomitant medications included pregabalin (LYRICA), butalbital, ascorbic acid (VITAMINS C), biotin, boron/ calcium/ Cimicifuga racemosa extract/ folic acid/ Glycine max extract/ Magnolia officinalis/ nicotinic acid/ pyridoxine hydrochloride/ riboflavin/ selenium/ thiamine/ tocopherol/ vitamin B12 NOS (ESTROVEN), Linum usitatissimum seed oil (FLAXSEED OIL), paracetamol (TYLENOL ARTHRITIS), and an unspecified stool softener and D (unspecified). The patient previously took amoxicillin and cinnamon oil and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 18Dec2020 at 08:00 PM, the patient experienced throbbing arm pain for 2 days, fever, chills, body aches, headache, and fatigue for 2 days - some of the same symptoms she had when she had COVID-19 back in Jun2020. The events were considered non-serious. Treatment was received for the adverse events including ibuprofen, paracetamol (TYLENOL), and famotidine/ ibuprofen (DUEXIS). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from "Throbbing arm pain" and "Fatigue" on 20Dec2020, and from the remaining events on an unspecified date.
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| 50 | 2021-02-23 | pain in extremity |
back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professi...
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back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 123302), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ergocalciferol (VIT D) and an unspecified vaccine (lot number: P 100242861) taken for an unspecified indication on 01Dec2020. The patient previously took the first dose of BNT162B2 (lot number: EL0140), at 50-years of age via intramuscular route, on 30Dec2020 at 03:30 pm on the left arm for COVID-19 immunization and four days after the injection, patient had severe low back pain, difficulty walking, standing, sitting. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, the patient experienced back pain along with bilateral leg pain. The patient did not receive any treatment for the reported events. The patient underwent lab test which included nasal swab test which showed negative result on 21Jan2021. The outcome of the events was recovering. The patient was not pregnant at the time of vaccination.
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| 50 | 2021-02-25 | vertigo, vertigo |
the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain positio...
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the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side; her scalp was itching and her back and stomach was itching; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 21Jan2021 15:00, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. On 21Jan2021 at 15:00 (last Thursday), the patient received the first dose. On 22Jan2021 (the day after the vaccine) at 07:00, her scalp was itching and her back and stomach was itching and that went away the same day. In the morning of 23Jan2021 (also reported as "either 22Jan2021 or 23Jan202"), the patient had dizzy spells, more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side. She stated that it usually happens when bending over, reaching up high, in a recline position or when switching sides on the pillow. She reported that she is still experiencing this symptom with no improvement and reported that dizziness worsened. In the morning of 26Jan2021, the patient reported that it was worst, the whole room was spinning but that spell went away after a few seconds. The patient reported her second dose was scheduled on 11Feb2021 and asked if the side effects after the second dose will be worse. The patient did not visit the emergency room and physician office. The outcome of the event "dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side" was not recovered; "the room was spinning/whole room was spinning" was recovered on 26Jan2021 (reported as "went away after a few seconds"); and "her scalp was itching and her back and stomach was itching" was recovered on 22Jan2021 (also reported as recovered on 23Jan2021). Information on lot/batch number has been requested.
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| 50 | 2021-02-26 | dizziness |
Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle a...
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Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.
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| 50 | 2021-02-28 | tingling, feeling cold |
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo...
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her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
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| 50 | 2021-03-01 | dizziness |
almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactab...
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almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.
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| 50 | 2021-03-01 | numbness, pain in extremity, pain, migraine, dizziness |
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp...
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dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
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| 50 | 2021-03-02 | pain |
Chills; body aches; head and neck pain; head and neck pain; sinusitis; This is a spontaneous report ...
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Chills; body aches; head and neck pain; head and neck pain; sinusitis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in left arm on 29Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included asthma, and Covid-19 prior to vaccination. Patient was not pregnant. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and had allergy. The patient experienced chills, body aches, head and neck pain, and sinusitis on 29Jan2021. No treatment was given. Patient has not tested for Covid after vaccination. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 50 | 2021-03-02 | dizziness |
dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old no...
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dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL1283, via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 at a single dose for COVID-19 immunization at a public health clinic/administration facility. Medical history included Gerd and allergies to tetracycline. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D), and unspecified multivitamins. No other vaccines in four weeks. No Covid prior vaccination. On 27Jan2021 10:00 AM (as reported), within 1 minute, the patient was dizzy and nauseas. The symptoms went away in10 minutes. No treatment for the events. She has not experienced any other side effects. No Covid test post vaccination. The outcome of the events was recovered on 27Jan2021 10:10.
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| 50 | 2021-03-02 | pain in extremity, tingling |
headache on right side of head; back went out from right side and cannot bend over; right leg hurts;...
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headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
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| 50 | 2021-03-02 | pain, dizziness |
lightheaded; tired; achy; This is a spontaneous report from a contactable consumer (patient). A 50-y...
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lightheaded; tired; achy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included borderline hypertension and allergies to latex. Patient was not pregnant. Concomitant medications included atorvastatin, lisinopril, and fish oil. The patient previously took morphine and had allergy. Patient reported that the day after the vaccination, she experienced lightheaded, tired, and achy at 2pm on 23Jan2021. She had these symptoms every day since. Some days it happens more often than others. It happens at different times such as lying down, walking, etc. No treatment was given. Outcome of the events was not recovered. Information regarding the lot/batch number has been requested.
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| 50 | 2021-03-09 | dizziness, weakness |
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s...
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joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
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| 50 | 2021-03-13 | vertigo, pain |
Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second v...
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Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second vaccine, but I wanted to update as to my experience. I got sick with the first one from about 4ish hours after until the next mid morning maybe? Then I felt bad again that second night. I had my vaccine (second) yesterday at 4 PM, and I felt OK going to bed but had a pretty pitiful night. I woke up at 5 AM and I felt horrible. That felt like someone took a pair of metal cymbals and slammed them together on my head. The tinnitus was strong. I also had body aches and joint pain and felt like I had the flu. I felt a little better around 1 PM, but felt bad again around 330. Now I'm miserable again with terrible body aches and chills (this was at 7:38 PM). I'm sure I will feel better in the morning, just wanted to share my experience." Sadly, since then, I have had tinnitus with a metallic ringing in both ears along with hearing loss. I had some vertigo one day but unsure if this was related. The tinnitus makes me very sad. I am a hospitalist and am happy to have been vaccinated, still. It has been 2 months today, and it remains, unrelenting. It is worse in the morning and at night. The hearing loss is difficult.
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| 50 | 2021-03-14 | pain in extremity |
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes...
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Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
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| 50 | 2021-03-14 | dizziness, tingling |
more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a ...
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more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
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| 50 | 2021-03-21 | weakness |
Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contac...
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Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6199), via an unspecified route of administration on 05Mar2021 15:15 in right arm as single dose for covid-19 immunisation. The patient medical history was not reported. Known allergies was no. The patient had no other vaccine in four weeks. Concomitant medications included fluticasone propionate (FLONASE); vitamin d; cyanocobalamin (VITAMIN B12). On 05Mar2021 16:00, the patient experienced weakness after vaccination, sore throat last night and today, choking when sleeping, she kept waking up from it. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Outcome of events were not recovered.
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| 50 | 2021-03-21 | migraine, pain in extremity, pain |
Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccin...
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Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccination. Presented to ED on 3/7/21 with back pain, no COVID symptoms reported and was discharged home. Presented to ED on 3/10/21 with generalized body aches, nausea, vomiting, and headache for 2 days. Noted mild cough and sinus congestion and was admitted to hospital for 5 days until 3/14/21. Returned to ED on 3/15/21 with worsening shortness of breath and was admitted to hospital for another 5 days until 3/19/21.
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| 50 | 2021-03-21 | tremor, tingling, dizziness, numbness, pain |
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need...
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Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
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| 50 | 2021-03-22 | dizziness |
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, ...
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4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device. This happened 3 times in approximately 2 hours on the day of vaccination. The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway. 03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
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| 51 | 2020-12-31 | tenderness, pain |
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ...
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*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
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| 51 | 2020-12-31 | pain, numbness, tingling |
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and fe...
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About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt "off" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.
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| 51 | 2021-01-01 | dizziness |
Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The diz...
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Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The dizziness began the day of vaccine around 8pm and has not subsided.
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| 51 | 2021-01-03 | pain in extremity |
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ...
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20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
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| 51 | 2021-01-03 | numbness | Ear pain pulling sensation, down my neck numbness jaw locking on same side of injection |
| 51 | 2021-01-03 | pain | Fever, chills, headache,body aches |
| 51 | 2021-01-03 | dizziness | Patient felt lightheaded for approximately 15 minutes |
| 51 | 2021-01-04 | numbness, tingling |
Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clav...
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Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
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| 51 | 2021-01-04 | migraine |
Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contact...
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Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | numbness |
Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for ...
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Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for over 4 hours and continues at this time, but lessening. Numbness also felt on tip of nose- lasted an hour on tip of nose and then dissipated. No treatments provided only watched for anything worsening.
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| 51 | 2021-01-04 | tingling, feeling hot, numbness |
Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she t...
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Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she then had numbness and tingling in her face and reported her throat felt warm.
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| 51 | 2021-01-04 | pain |
achy, chills, fatigue, headache starting a few hours after vaccine. Resolved with sleep, tea and ov...
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achy, chills, fatigue, headache starting a few hours after vaccine. Resolved with sleep, tea and over the counter Sudafed 4 hour night time with ibuprofen.
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| 51 | 2021-01-04 | pain in extremity |
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning ...
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felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-04 | dizziness, tingling, numbness |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-04 | numbness, tingling |
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to...
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swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | tingling |
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands...
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tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.
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| 51 | 2021-01-04 | dizziness |
waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - fe...
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waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.
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| 51 | 2021-01-05 | lightheadedness, dizziness, tingling |
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ...
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15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
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| 51 | 2021-01-05 | pain |
Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I...
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Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I have taken a tums and just slept since 1/5/2021 at 4:00p. I have no appetite.
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| 51 | 2021-01-05 | dizziness | Headache, light headed, instant nasal congestion and malaise |
| 51 | 2021-01-05 | numbness, speech disorder |
Patient complained of episodes of numbness on left side of face along with difficulty speaking lasti...
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Patient complained of episodes of numbness on left side of face along with difficulty speaking lasting up to 5 minutes. She has had 4 episodes since vaccination, last one was 1 week ago
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| 51 | 2021-01-05 | dizziness |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021  Date: 1/6/2021  Subjective Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.  She was given the Pfizer vaccination in the left deltoid muscle.  During her 15 minute waiting period after the injection, the patient began to experience dizziness, flushing and HA. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.  This provider was notified of patient reaction and she was then assessed in the emergency bay area.  Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.  Hx: pt has history of breast CA and is on oral chemotherapy.   ALLERGY REVIEW OF SYSTEMS: All other systems negative    Objective  Vitals Vitals:  01/06/21 1415 01/06/21 1427 01/06/21 1443 BP: (!) 168/89 (!) 154/94 (!) 154/84 Pulse: 87 85 72 SpO2: 99% 98% 99%  Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.    Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.  Pt was given Food and water and started to feel better. For her headache she was given Tylenol 1000 mg orally. Pt left clinic at 2:45 pm.    Electronically Signed 1/6/2021 2:44 PM  Â
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| 51 | 2021-01-05 | dizziness |
c/o lightheadedness and light headache. Cold pack applied to nape of neck, head down, felt better an...
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c/o lightheadedness and light headache. Cold pack applied to nape of neck, head down, felt better and returned to work Narrative: c/o lightheadedness and mild headache. resolved and returned to work
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| 51 | 2021-01-05 | pain |
caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vacc...
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caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vaccine was scheduled on 06Jan2021; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Nausea; Headache; Body aches; fatigue; Cold sweat; This is a spontaneous report from a contactable other health professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as either EK5730, ER5730, or EX5730), via an unspecified route of administration on 18Dec2020 16:00 at single dose at left deltoid for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously had shingles shot in Sep2020, previous shingles shot either three months or six months prior to the one in Sep2020 (2020), both for immunization, and severe myalgia and fever that lasted for two days after the second shingles shot (adverse events followed prior vaccinations). It was reported that did a callback as caller couldn't hear properly. Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020. Want to know if it's safe for her to get the second dose. The patient received Pfizer COVID-19 Vaccine on 18Dec2020 at 16:00. Patient had a couple days worth of symptoms. Now patient had COVID. Patient believed most likely got COVID from her son who was home from college. She was in between dosages of COVID-19 Vaccine. Looked like from research her quarantine would be done on 05Jan2021 and her second dose of COVID-19 Vaccine was scheduled on 06Jan2021. Everything she had read stated if her symptoms were gone to go ahead and get the second COVID-19 Vaccine. Patient wanted to know if Pfizer was doing any studies regarding people who test positive for COVID after receiving the COVID-19 Vaccine. Not sure if Pfizer would be interested in doing antibody studies. Declined obtained COVID-19 Vaccine through work Clarified caller's days worth of symptoms as: Headache the same evening as vaccination. Body Aches: began overnight on 18Dec2020. Fatigue that lasted all week, began overnight on 18Dec2020. Cold sweats: Lasted two days and began overnight on 18Dec2020. Nausea: began on 21Dec2020, not sure if it was related to COVID-19 Vaccine or not. The reporter considered the events weren't serious, but felt like she was having an immunological response. Diagnosed with COVID Seriousness: As of now, not serious. Is having a recurrence of all of those same symptoms as the COVID-19 Vaccine and then some. Lot number provided from patient card. Stated she was unable read it accurately. would take picture in case Pfizer wanted it. Stated lot number was either EK5730, ER5730, or EX5730. A sample of the product was not available to be returned. Vaccination facility type was Hospital, not administered at military site. No additional vaccines administered on same date of Pfizer suspect. No adverse events required a visit to. No prior vaccinations received within 4 weeks. The outcome of the event "Cold sweat" was recovered on 20Dec2020. The outcome of the other events was unknown. The reported considered the events Headache, Body aches, fatigue, Cold sweat, Nausea were related to the suspect drugs. Information on the lot/batch number has been requested.; Sender's Comments: The reported COVID test positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
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| 51 | 2021-01-05 | dizziness, weakness, pain in extremity, tingling |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-05 | dizziness | lightheadedness, spontaneous resolution |
| 51 | 2021-01-06 | dizziness |
AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. ...
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AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. THE MORNING OF 01/05/2021, I DEVELOPED CHILLS WITHOUT FEVER. WENT TO MY FAMILY PRACTICE, LIFETIME MEDICINE, AND WAS SEEN BY NIDA ARIF, PA FOR ABOVE PERSISTING SYMPTOMS. AN EKG WAS DONE IN THE OFFICE RESULTING IN NORMAL SINUS RHYTHM. AS OF 01/06/2021, CHILLS, DIZZINESS AND LIGHT-HEADEDNESS RESOLVED. PALPITATIONS CONTINUE TO PERSIST AS OF 01/07/2021 WHEN THIS REPORT WAS FILLED OUT AND SUBMITTED.
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| 51 | 2021-01-06 | dizziness |
Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration ...
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Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration began to feel lightheaded, sweaty and flushed. Pt states this is not uncommon for her, has history of this after shots and occurs spontaneously throughout the day. Pt's face was flushed but did not develop any tongue or lip swelling, denied sob or respiratory difficulty. On exam op clear, no swelling to lips, tongue, no stridor, lungs cta bil, no wheezing, cor rrr s1s2 no m/g/r, abd soft nontender, ext no c/c/e, left upper ext injection site without redness or swelling. Vital signs were T 97.5, bp 154/97 p 95, o2 sat 97%, bp 146/80, p98, 100% 148/05 p 102 99%, 163/92 p83 o2 99%. Pt was observed for the next approx. 15-20 mins, given water and improved. Walked around the clinic with the pt who felt comfortable to be discharged. She was instructed to monitor her symptoms, follow up with her primary md regarding pretreatment prior to second vaccine and to go straight to the ED if her symptoms progress or worsen. Pt understood and agreed with instructions. Pt works in the facility and will be around medical personnel until 8pm.
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| 51 | 2021-01-06 | pain | Had body aches and fatigue for 4 days. Sore throat developed after second day. |
| 51 | 2021-01-06 | migraine |
Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That nig...
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Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That night woke up with muscle spasms all over her body and took her temp which was 101. The muscle spasms stopped at 0300 on 12/31. After that she developed a migraine. Headache last 22 hours and then just went away. She was tired the following day 1/1. All symptoms resolved on 1/2. She received the first vaccine in the ED and is scheduled to receive the second one in the ED as well. She has h/o anaphylaxis to food and bugs.
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| 51 | 2021-01-06 | pain |
Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walkin...
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Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walking on broken bones. All over body pain.
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| 51 | 2021-01-06 | pain | chills and severe body aches |
| 51 | 2021-01-06 | pain | fever 102F aches |
| 51 | 2021-01-06 | pain |
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ...
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had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
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| 51 | 2021-01-07 | pain | Fever and body aches 12 hours after vaccine. Fever 104.1 during the night, body aches, headache |
| 51 | 2021-01-07 | pain in extremity |
I started few hours later started feeling thought it was stress. The next morning around 9am high mo...
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I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
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| 51 | 2021-01-07 | pain, weakness |
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ...
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Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
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| 51 | 2021-01-07 | pain in extremity, pain |
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,...
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Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
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| 51 | 2021-01-07 | pain |
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achine...
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Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
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| 51 | 2021-01-07 | dizziness, pain |
Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, hea...
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Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, headache, mild muscle aches, chills. After about 2 hours, did not improve therefore was directed to the ED. EKG was normal. CBC, CMP, TFTs all normal. Was monitored for a couple hours and HR improved. At home it took until 17:40 for HR to consistently be 100 or less.. still feel fatigued, headache, and achy.
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| 51 | 2021-01-07 | vertigo |
feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This i...
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feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19, lot number and expiry date not reported), intramuscular on 03Jan2021 13:15 at a single dose on right arm for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient reported, "I'm feeling very shaky and dizzy when I stand up on 03Jan2021 14:30. No treatment was given for the events. The outcome of the events was unknown. The events were considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was in Nursing Home/Senior Living Facility. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. Information about lot/batch number has been requested.
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| 51 | 2021-01-07 | pain | headache, body aches, & joint pain |
| 51 | 2021-01-08 | dizziness, lightheadedness | Hypotension 90/60 experienced; Dizziness; almost passed out; rapid heart beat and unable to breath |
| 51 | 2021-01-08 | dizziness, tingling |
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ...
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Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
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| 51 | 2021-01-08 | lightheadedness, dizziness | c/o dizziness, near-syncope 10 minutes post-vaccination |
| 51 | 2021-01-09 | numbness, migraine, pain, tingling |
1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and...
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1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and tingling in the arm the vaccine was administered in
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| 51 | 2021-01-09 | pain |
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13...
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1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
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| 51 | 2021-01-09 | tingling, pain, pain in extremity |
1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever ...
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1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | pain, pain in extremity, tingling |
2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tin...
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2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | pain |
Low grade fever 100.2, severe body aches, fatigue, started around 8:00 pm 1/7/21, worsened throughou...
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Low grade fever 100.2, severe body aches, fatigue, started around 8:00 pm 1/7/21, worsened throughout the night. Intense fatigue and body aches continued throughout 1/8/21. 1/9/2021, Fatigue , intermittent chills subside.,mild generalized body aches continue.
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| 51 | 2021-01-09 | tingling, numbness |
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to h...
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Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
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| 51 | 2021-01-09 | pain in extremity |
Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move ...
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Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move the left arm. States pain is 10 on a 10-point pain scale . Has been on Advil and Tylenol with no relief
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| 51 | 2021-01-09 | migraine |
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm...
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Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
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| 51 | 2021-01-10 | feeling hot |
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920...
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0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
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| 51 | 2021-01-10 | pain, pain |
12/19-Chills at 1000, Body aches and headache at 1230, fever 101.5. Pt reported fever increased to ...
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12/19-Chills at 1000, Body aches and headache at 1230, fever 101.5. Pt reported fever increased to 106 at which time she went to the ER. ER reports fever on arrival of 100.8. IV Zofran and IVF admin in ER and d/c. F/u 12/20 1130-pt improved and at home.
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| 51 | 2021-01-10 | pain |
36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node ...
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36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node in armpit of left arm
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| 51 | 2021-01-10 | pain |
Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m....
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Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m. next day all continued except fever, down to 98 - 99. Pain in my arm is worse, not able to use arm much.
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| 51 | 2021-01-10 | pain |
Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache...
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Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache; feeling sick; Sneezing; This is a spontaneous report from a contactable nurse (patient, front line health care worker). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via an unspecified route of administration in the left arm on 28Dec2020 (at 10:30 or 11:00 AM) at single dose for COVID-19 immunization. Medical history included hypertension, diabetes, and stroke, all reported as family history (her parent). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient had body ache (reported as medically significant) on 01Jan2021 with outcome of recovering, had been sick for a week/ very ill on 28Dec2020 with outcome of unknown, sneezing on 28Dec2020 with outcome of not recovered, chills on 01Jan2021 with outcome of unknown, headache on 01Jan2021 with outcome of recovering, coughing on 01Jan2021 with outcome of not recovered, tiredness on 01Jan2021 with outcome of unknown, nasal congested on 01Jan2021 with outcome of not recovered, feels like her sinus were blocked on 01Jan2021 with outcome of unknown. Treatment was received for the events. Reported she had a lot of sickness, by evening that day (28Dec2020) she got sneezing and feeling sick. Then the next day was the same, then the third day. She became very ill with chills, body ache, headache, coughing, and tiredness on 01Jan2021 (also reported as 3 days later vaccination). And she had no fever, but stated she had been sick for a week. Added the headache and body ache were a little better but still she felt so congested. Clarified she had nasal congested that feels like her sinus were blocked. She treated herself with acetaminophen, once daily 500 mg by mouth starting 01Jan2021. Added the body ache pain was still on the back of her chest but her legs and arms were better. She used steam inhalation for the congestion. She was not scheduled for the next dose yet, she was just waiting. The patient was wondering if she should do a test for COVID 19. Mentioned she had been healthy all through this year and digging in the COVID 19 all the time but then after the vaccine she got so sick. This was the first day she could get up and did anything. Advised caller to consult her HCP.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the body ache. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-10 | dizziness | DIZZINESS, HEADACHE AND TOTAL EXHAUSTION FOR 2 DAYS. |
| 51 | 2021-01-10 | dizziness | Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated |
| 51 | 2021-01-10 | dizziness |
Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours late...
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Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours later and still currently active with these symptoms.
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| 51 | 2021-01-10 | pain |
Had muscles aches headache and some neck pain 15 mins after vaccination. Patient is still currently ...
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Had muscles aches headache and some neck pain 15 mins after vaccination. Patient is still currently having these symptoms. Headaches and body aches have worsened.
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| 51 | 2021-01-10 | pain |
I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction...
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I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction on 12/19/20. Horrible fatigue, body aches. My second dose was given on 1/7/21. After 6 hours, I felt myalgias, arthralgias, skin sensitivity to anything that touched me. Severe fatigue and headache. Took Tylenol with no relief. The worst day hit at 1/8/21 at 3:00 a.m. I could not move without extreme pain. Sweating and chills. No appetite. Had to be assisted to toilet. Tried to go into hospital to do vaccine clinic today, 1/11/21 and had to return home as I was extremely fatigued and excessive sweating.
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| 51 | 2021-01-10 | dizziness |
On dec 29 I began fever, chills and bad headache. Tested negative for covid and flu. Also fatigue. ...
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On dec 29 I began fever, chills and bad headache. Tested negative for covid and flu. Also fatigue. Then dizzy and just didn?t feel good. Tested negative again on January 4. But still dizzy and fatigue.
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| 51 | 2021-01-10 | pain |
Shingles, diagnosed on January 7 2021 by my PCP. First symptoms (pain and rash) first appeared Janua...
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Shingles, diagnosed on January 7 2021 by my PCP. First symptoms (pain and rash) first appeared January 5th.
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| 51 | 2021-01-10 | pain, pain in extremity |
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac...
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Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
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| 51 | 2021-01-10 | pain |
Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sle...
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Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
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| 51 | 2021-01-10 | pain in extremity, pain |
Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience seve...
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Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience severe headache and nausea. They also developed chills, body ache, and arm pain at night. On a follow up call on 1/11/2021, they reported that their symptoms resolved on 1/8/2021.
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| 51 | 2021-01-11 | numbness |
"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro ...
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"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg. Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. "
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| 51 | 2021-01-11 | pain in extremity |
10 hours later after received vaccine developed Left arm pain . During the night wake up due to seve...
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10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
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| 51 | 2021-01-11 | pain | Body aches, chills, fever |
| 51 | 2021-01-11 | pain in extremity |
COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/...
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COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
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| 51 | 2021-01-11 | pain |
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy...
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Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
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| 51 | 2021-01-11 | dizziness |
Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pai...
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Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-11 | feeling hot, pain in extremity, pain |
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ...
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Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
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| 51 | 2021-01-11 | pain |
Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left ...
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Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
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| 51 | 2021-01-11 | dizziness, pain | Nausea, body aches, dizziness, mouth/tooth pain |
| 51 | 2021-01-11 | swollen extremities, pain |
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pa...
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Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
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| 51 | 2021-01-11 | migraine |
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; S...
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Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | pain, pain in extremity |
Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over...
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Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over my body and fever 103F. Still have severe headache 36 hours late and fever 100F.
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| 51 | 2021-01-11 | feeling hot | Warm feeling in chest Better after waiting and drinking water |
| 51 | 2021-01-11 | dizziness, pain |
achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactab...
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achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiration date: Mar2021), via an unspecified route of administration at the left arm on 05Jan2021 12:10 at a single dose for COVID-19 immunization in the hospital. The patient has not had any vaccines in four weeks. The patient has no medical history. There were no concomitant medications. The patient received the COVID vaccine on 05Jan2021 and confirmed that it was the first dose she received of the COVID vaccine. She clarified that she started to have dizziness, disorientation, nausea, achiness and headache. The dizziness, disorientation and nausea started about 8 hours after she received the vaccine, 05Jan2021 20:10. She stated that she was just trying to push through with the side effects. She woke up in the morning, 06Jan2021, feeling both achy and with a headache. She stated that she had the achiness that was regular and knew would normally come along with it. However, she also had a headache. The outcome of the events was not recovered.
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| 51 | 2021-01-11 | dizziness, numbness |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | pain, pain in extremity |
body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contacta...
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body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 51 | 2021-01-11 | pain |
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round ar...
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erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 51 | 2021-01-12 | pain in extremity, dizziness |
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies;...
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Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
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| 51 | 2021-01-12 | tingling |
Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to ...
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Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to right toe, right jaw lock, and headache on right side 4/10 pain.
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| 51 | 2021-01-12 | pain |
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 d...
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Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days. Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
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| 51 | 2021-01-12 | pain | I had what felt like a sinus infection, sore throat, stuffy nose, body aches and fatigue. |
| 51 | 2021-01-12 | pain, pain in extremity, tremor | Left arm pain, armpit pain, body aches, shaking chills, nausea, extreme tiredness |
| 51 | 2021-01-12 | pain in extremity |
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min...
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No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
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| 51 | 2021-01-12 | pain in extremity |
Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain...
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Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain.
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| 51 | 2021-01-12 | pain, dizziness |
Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects ...
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Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects about 2am reporting elevated temp of 101, dizziness, muscle aches all over, nausea, and just didn't feel well. She states she developed a knot on her arm at injection site with redness and itching. She reports this knot was hard initially but next day was better. She reports these side effects lasted all weekend.
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| 51 | 2021-01-12 | tingling |
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea...
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Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
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| 51 | 2021-01-12 | pain in extremity, pain |
The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I ...
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The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I began to get fatigued chills overall body aches but was afebrile. I also had nasal congestion and sneezing for 4 hrs. that resolved. At 12 noon I felt progressively worse and had to leave work. I got home and my temp was 100.2 and took more Ibuprofen at 1 PM. At 2PM the body aches and chills were pretty severe- my temp rose to 103.2. I took more Ibuprofen and alternated with TYLENOL and it returned to normal at 10 PM. I notified my Drs office and had a telemedicine visit with Dr at 4PM who thought it was a normal immune response but suggested getting a COVID Test in the meantime before returning to work. I woke up this morning afebrile with no issues notified employee health got a referral and had my COVID test completed at 09:30am. The urgent care MD strongly urged me to report to VAERS, not just CDC as I had yesterday. My COVID tests are still pending.
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| 51 | 2021-01-12 | dizziness |
dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare p...
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dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, then the second dose (lot number: EK9231, expiry date not reported) via intramuscular route of administration the left deltoid muscle on 06Jan202, both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience dizziness, flushing and HA (headache). She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, and lightheadedness. No therapy/ treatment was given. Events were non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-12 | dizziness |
gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a co...
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gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a contactable other HCP(patient). A 51 years old female patient received first dose BNT162B2(lot number EL0140), via an unspecified route of administration on 29Dec2020 08:00 at the 51 years old at Arm Left at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient had her first dose on 29Dec2020, she had no fever or chills and she got it at 8AM, and she woke up on 30Dec2020, and for the last 9 days when she wakes up, she was gut wrenchingly nauseated. It lasted like up to sometimes until noon, she still had a little nausea now, and it is almost noon there, and this comes along with being so nauseated. She was having a pretty moderate stomach ache on 30Dec2020, especially after eating, then she was really felt flushed and dizzy on 30Dec2020, but she thought because the nausea was so bad. She had a headache on 30Dec2020 and lasted for 5 days. She was not sick prior to the COVID vaccine. The outcome of the event Headache was recovered on 04Jan2021, the other events was not recovered.
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| 51 | 2021-01-13 | pain in extremity, tenderness |
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g...
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Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
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| 51 | 2021-01-13 | pain in extremity |
Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lif...
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Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lift arm for about 1 hour, improved after ibuprofen. Significant fatigue for 2 days. By day 3, all symptoms resolved.
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| 51 | 2021-01-13 | vertigo, numbness, tingling, speech disorder |
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a...
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Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
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| 51 | 2021-01-13 | pain | Extreme fatigue, body aches, intermittent chills and headaches for 30 hours |
| 51 | 2021-01-13 | feeling hot | Felt hot and flushed |
| 51 | 2021-01-13 | tingling, numbness, dizziness |
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no se...
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Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
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| 51 | 2021-01-13 | pain |
I had a fever of 101.6 and chills, body aches and headache. It ran for 4 days. I went back to work ...
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I had a fever of 101.6 and chills, body aches and headache. It ran for 4 days. I went back to work on 12/28/2020. I received dose 2 on 01/12/2021.
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| 51 | 2021-01-13 | weakness, feeling cold, pain |
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f...
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Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
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| 51 | 2021-01-13 | pain |
Please note: I had documented symptomatic COVID19 infection March 2020. Recovered fully without lo...
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Please note: I had documented symptomatic COVID19 infection March 2020. Recovered fully without long term symptoms. SARS-COV2 Ab testing was positive on 12/6/20 Dose #1 Vaccine was received 12/22/20 at 3:30pm - on 12/23 I woke up at 5:30am with fever, body aches and fatigue - fever went up to 103F and I spent the day in bed - symptoms resolved approximately 12hr later (around 5:30pm) I then felt fine until 1/2/21 (10 days later) when I awakened with fever, generalized body aches and fatigue - this time fever was lower to 100.4. I again spent much of the day in bed and symptoms resolved after 8 hrs
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| 51 | 2021-01-13 | pain | fever, body ache, malaise. called in sick to work. |
| 51 | 2021-01-13 | pain in extremity |
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath...
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received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
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| 51 | 2021-01-14 | pain, weakness |
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen...
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2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever. 1st dose: no ae to report
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| 51 | 2021-01-14 | numbness |
Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syn...
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Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syndrome), it lasted 5 hours and dissipated after. Also developed right ear pain and jaw pain, which is still present. At the same time my right side of my face was numb which lasted a couple days.
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| 51 | 2021-01-14 | weakness, pain, dizziness |
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ...
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Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
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| 51 | 2021-01-14 | pain | Itch in throat Cough Fever 99.6 F Body aches Short of breath |
| 51 | 2021-01-14 | pain, pain | Itch in throat Cough Fever 99.6 F Body aches Shortness of breath Headache |
| 51 | 2021-01-14 | pain |
Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours a...
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Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours after injection, lasting approx 29 hours. Approx 48 hours after injection swollen, tender area approx size of golf ball under left arm ( injection arm) and conintues to be there on 3rd day
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| 51 | 2021-01-14 | pain |
R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is...
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R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is a spontaneous report from a contactable Physician (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL6142), via an unspecified route of administration on 07Jan2021 14:45 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included hypothyroidism, hx of Hodgkins from 1994, breast cancer from 2005. Concomitant drug included levothyroxine sodium (SYNTHROID). The known allergies included Bactrim, bacitracin, non-ionic contrast. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Right arm pain - at site of injection, significant nausea, headache, body aches and chills. fatigue on 07Jan2021 20:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
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| 51 | 2021-01-14 | seizure |
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re...
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Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
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| 51 | 2021-01-14 | dizziness |
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling...
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Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
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| 51 | 2021-01-14 | pain |
Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This cont...
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Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This continued to get worse on Friday. By Saturday, patient felt she could not get comfortable and was more short of breath. She went to the ER and after multiple tests they found multiple pulmonary emboli. Of note, patient took a long flight on 1/6 and is on hormone replacement therapy.
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| 51 | 2021-01-14 | pain |
Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable co...
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Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 16Dec2020 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. It was unknown if other vaccine was administered in four weeks. On 07Jan2021, the patient experienced severe headache, body ache, malaise, pain and nausea fit for 30 hours. Prior vaccination the patient had no COVID. It was unknown if the patient was COVID tested post vaccination. No treatment received for the events. The patient recovered from the events on unspecified date in Jan2021. Information on the batch number has been requested.
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| 51 | 2021-01-14 | pain | Tiredness, Body aches, Headache, Chills started 1/14 at 1500 . I am still having symptoms today. |
| 51 | 2021-01-14 | feeling hot | body itching, eye itching and irritation, body warm, chest tightness, bradycardia |
| 51 | 2021-01-14 | feeling hot | body itching, eye itching and irritation, body warmth, chest tightness, bradycardia |
| 51 | 2021-01-15 | pain |
1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headac...
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1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headache, mild fever 99.9 3rd day - body aches only
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| 51 | 2021-01-17 | migraine |
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ...
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BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
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| 51 | 2021-01-17 | pain in extremity |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-17 | pain |
Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right ar...
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Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right arm where she got the vaccine shot that is painful; Cold chills; Body aches; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: SJ1865), via an unspecified route of administration on 06Jan2021 10:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included ongoing Diabetic- Started 4-5 years ago. Concomitant medication included ongoing metformin for diabetic. The patient clarified the side effects she experienced were cold chills, body aches, and stiffness on the right arm where she got the vaccine shot and there was pain. The cold chills started late afternoon on 06Jan2021 around 1:00 PM or 1:30PM. She confirmed these have gone away and she has recovered completely. The body aches started around this same time as well. The stiffness on the right arm where she got the vaccine shot is painful. She noticed the stiffness and pain about 30 minutes after she got the vaccine, it was like 10:30 AM when she noticed this. She is no longer hurting and the stiffness has gone away. It went away on Saturday late in the evening like 7:00PM or 8:00 PM. The outcome of the events was recovered on 09Jan2021.
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| 51 | 2021-01-18 | facial paralysis |
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we...
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9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
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| 51 | 2021-01-18 | unresponsive to stimuli |
COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff wi...
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COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.
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| 51 | 2021-01-18 | pain | Fatigue, wheezing, soreness, palpitations |
| 51 | 2021-01-18 | pain in extremity, pain |
Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; ...
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Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.
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| 51 | 2021-01-18 | pain, migraine |
Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sne...
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Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.
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| 51 | 2021-01-19 | dizziness |
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , D...
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Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears. These symptoms have been all 7 days.
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| 51 | 2021-01-19 | dizziness |
Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints ...
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Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints of total body urticaria and light headed
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| 51 | 2021-01-19 | dizziness |
Vaccine administered at 4:40 PM. At 4:50 PM patient reported sudden onset cough, dizziness, and thro...
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Vaccine administered at 4:40 PM. At 4:50 PM patient reported sudden onset cough, dizziness, and throat closing. Onsite nurses attended to patient immediately. Vital signs stable. 911 called. EMS transport at 5:00 PM to hospital.
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| 51 | 2021-01-19 | pain | chills, headache, achy |
| 51 | 2021-01-19 | pain |
immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday mornin...
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immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday morning 1.9.21; foggy mind body aches Symptoms subsided Tuesday morning 1.12.21
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| 51 | 2021-01-21 | dizziness |
0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Para...
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0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Paramedics arrived, Hx of panic attacks that precipitate ED visit, not on any meds.
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| 51 | 2021-01-21 | pain |
1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (...
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1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (ear), chills, body aches, joints achy, headache, slight sore throat, couldn't sleep. Took 2 butalbital and drank Pedialyte; forehead temp was 100.1 F by 5 am, and 99.7 F by 6 am 7:30 am (1/22/2021) fever returned and was 102.2 F (forehead) and 101.4 in ear. All other symptoms remain the same. Took 2 butalbital and drank more Pedialyte Called doctor and left voicemail with nurse to put these notes in my chart It should be noted that I had Covid-19 from onset of symptoms on 11/13/2020 and had symptoms through 11/29/2020. I had two visits to urgent care for fluids and medication (11/20/2020 & 11/29/2020). Exposure came from my husband who presented with symptoms on 11/12/2020 and contact tracing revealed his exposure was on 11/09/2020
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| 51 | 2021-01-21 | vertigo, dizziness, pain |
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl...
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An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
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| 51 | 2021-01-21 | pain | CHills Fever Body Aches Headache |
| 51 | 2021-01-21 | pain |
Developed a fever and bad body aches around 9:00 pm the evening of the shot. My stomach was very up...
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Developed a fever and bad body aches around 9:00 pm the evening of the shot. My stomach was very upset and couldn?t eat. Had bad headache.
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| 51 | 2021-01-21 | pain | Fever chills body aches |
| 51 | 2021-01-21 | migraine, pain, pain in extremity |
HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVE...
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HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVER THE FIRST 24 HRS AND THEN STARTED TO DISSIPATE AFTER ABOUT 36 HRS AND WERE COMPLETELY GONE IN 48 HRS. TOOK ADVIL. SLEEP.
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| 51 | 2021-01-21 | difficulty speaking |
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work...
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I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
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| 51 | 2021-01-21 | pain | Injection site pain, body aches, fatigue, throat pain. Resolved. |
| 51 | 2021-01-21 | feeling hot |
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it...
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Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
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| 51 | 2021-01-24 | dizziness, pain |
I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chi...
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I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chills. At 2am, I woke with more chills and a splitting headache. I took Tylenol which decreased the symptoms. All day on Sunday, I had a horrible headache, a fever of 101F, body aches (muscles and joints), cramping, nausea, terrible fatigue. I took Tylenol every 4 hours which did help some. Today, I feel fatigued, fever is gone, I feel nauseated.
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| 51 | 2021-01-24 | pain in extremity |
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7...
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I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
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| 51 | 2021-01-24 | dizziness, lightheadedness |
short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do...
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short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the left arm, on 03Jan2021 at 10:00, at a single dose, for covid-19 immunization. Medical history included known allergies (unspecified). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a doctor's office/urgent care. The patient experienced 3 "waves" or what her many coworkers were describing as "whooshes". The first two occurred minutes apart approximately 4-5 minutes post vaccine-last less than one minute each. The 3rd wave occurred after lunch approximately 3 hours later-lasted approximately 2 hours but not as intense as the first times. The patient further described the symptoms as "felt like a rush" (unspecified) experienced when receiving epinephrine. She was short of breath, lightheaded, dizzy, like pre-syncope as she felt like she could pass out but did not do so. The events occurred on 03Jan2021. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. The patient has not been tested for COVID-19 since vaccination.
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| 51 | 2021-01-25 | feeling hot, dizziness |
about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. ...
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about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.
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| 51 | 2021-01-25 | pain |
diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; F...
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diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; Fever; Body aches; swollen lymph nodes under left armpit; Exposed to COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 51-year-old female patient received the first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 08:30 in left arm at single dose for covid-19 immunization. The patient medical history was none. Family medical history was no. Patient had been taking vitamin supplements. No vaccinations were taken within 4 weeks. Patient received first COVID-19 Vaccine on 21Dec2020 around 08:30. Between that three weeks period, patient was diagnosed with COVID. Patient was exposed the following weekend. Took four tests to finally test positive within a four-day-span. Patient was exposed to COVID on 26Dec2020. On 28Dec2020, patient experienced swollen lymph nodes under left armpit. Progressively got more sensitive on 29Dec2020. Patient thought maybe it was a side effect of the COVID-19 Vaccine. Wednesday morning, 30Dec2020, around 10:00 patient noticed body aches. Around 12:00 patient noticed a fever. On 30Dec2020, patient had a 24-hour lab test to check for COVID. All other COVID tests performed were rapid tests. First COVID test was on 30Dec2020. Patient had another COVID test on 31Dec2020, and two COVID tests on 02Jan2021. Patient was tested positive for COVID on 02Jan2021. COVID test that resulted positive was a rapid test in the emergency room. Patient was diagnosed with Covid-19 after the 1st dose. Patient was in the emergency room with pneumonia which occurred on 02Jan2021. It was confirmed patient was discharged from the emergency room six to seven hours after arrival. Lot number from patient card was either EJ1685 or ET1685. Caller unable to confirm lot number from patient card. Chest X-ray was what sent her to emergency room labs and blood work done on 02Jan2021 in emergency room. Labs were done in clinic a couple days before flu and strep test both negative on an unspecified date. Patient didn't remember all tests and results. Outcome of all events were unknown. Caller would like to know whether she should take the 2nd dose or not. Information on the lot/batch number has been requested.
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| 51 | 2021-01-25 | tingling, numbness |
numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on...
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numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/numb all over her spine; loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; paresthesia; having trouble with dexterity; This is a spontaneous report from a contactable physician (neurologist) via a Pfizer-sponsored program. A 51-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in left arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced allergy. The physician reported that the patient received the first dose of the vaccine and has been experiencing numbness for 10 day from an unspecified date. This patient received the injection in the left arm and she started experiencing numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine, she's still experiencing ongoing numbness the numbness in her 4th and 5th digit. The patient experienced loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; and felt numb all over her spine, all on unspecified dates. The patient was having trouble with dexterity. The physician ordered an MRI for the patient but does not have the results back yet. The physician asked if it is safe for the patient to get the second dose. The second dose will be on 15Jan2021. The outcome of the event numbness was not recovered, and the outcome of the remaining events was unknown. Information on the lot/ batch number has been requested.
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| 51 | 2021-01-25 | numbness, feeling hot |
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t...
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warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
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| 51 | 2021-01-26 | dizziness | Dizziness, nausea, fever, chills, HA, muscle aches, fatigue |
| 51 | 2021-01-26 | pain |
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d...
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Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
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| 51 | 2021-01-26 | pain | Nausea, fever, bodyaches, headache, fatigue, rash |
| 51 | 2021-01-26 | dizziness |
Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is rangin...
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Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is ranging from 130s-180s, becoming more elevated with activity. At rest it's varying from 90s to 130s. It is now 1/27/21 at 8:50am and symptoms have continued.
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| 51 | 2021-01-26 | pain |
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the...
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Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS). The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks. Outcome of the event "Since the vaccination, has the patient been tested for COVID-19:Yes" was unknown, while recovering for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 51 | 2021-01-26 | weakness |
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t...
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metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 51 | 2021-01-27 | tingling, numbness |
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf...
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slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
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| 51 | 2021-01-28 | numbness |
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a...
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Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
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| 51 | 2021-01-28 | feeling hot |
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi...
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Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
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| 51 | 2021-01-28 | feeling cold, tingling, pain in extremity |
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;...
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Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
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| 51 | 2021-01-28 | inability to speak, dizziness |
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble...
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cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
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| 51 | 2021-01-28 | vertigo, dizziness |
vertigo; dizzy; nauseated; This is a spontaneous report from a contactable consumer, the patient. A ...
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vertigo; dizzy; nauseated; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in the left arm on 16Jan2021 at 15:30 PM (at the age of 51-year-old) as a single dose for COVID-19 vaccination. Medical history reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), sertraline hcl (ZOLOFT), zolpidem tartrate (AMBIEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jan2021 at 07:00 AM, the day following her vaccine, the patient had severe vertigo. It lasted most of the day. She was extremely dizzy and felt nauseated. She did not throw up, however. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, dizzy, and nauseated was recovered on unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-30 | dizziness | Throat closing, palpitation, lightheadedness, cough with bronchospasm |
| 51 | 2021-02-02 | unresponsive to stimuli, pain in extremity |
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de...
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**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
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| 51 | 2021-02-02 | facial paralysis, numbness |
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n...
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On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
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| 51 | 2021-02-03 | pain, dizziness, feeling of body temperature change, pain in extremity |
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm...
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chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
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| 51 | 2021-02-08 | numbness, facial paralysis, one side paralysis |
1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to ...
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1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: "Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift." Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.
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| 51 | 2021-02-08 | migraine, dizziness, pain |
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10...
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yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
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| 51 | 2021-02-10 | pain in extremity, dizziness, pain |
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch...
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2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-02-14 | pain, swollen extremities, weakness |
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t...
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Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
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| 51 | 2021-02-17 | facial paralysis |
Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a cont...
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Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.
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| 51 | 2021-02-17 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patien...
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Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 51 | 2021-02-19 | difficulty speaking |
Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treate...
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Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.
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| 51 | 2021-02-21 | weakness, pain |
Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired ...
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Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired - continuing for 1 week Tired/low energy - for 2 weeks.
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| 51 | 2021-02-21 | dizziness, one side paralysis, weakness |
Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath wit...
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Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath with activity ongoing. Patient normally very active and has not chronic conditions
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| 51 | 2021-02-21 | tingling |
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO wi...
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Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
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| 51 | 2021-02-21 | pain, pain in extremity, migraine, numbness |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-22 | pain |
A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headac...
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A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headache, chills, fatigue, diarrhea, sweating, injection site pain, stomach pain and upset. I have been taking Tylenol and Ibuprofen to help with the aches and pains and NyQuil at night to help with fever and aches. It is helpful. I have been eating a BRAT diet and drinking a lot of vitamin water with 0 sugars.
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| 51 | 2021-02-22 | feeling hot |
Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensatio...
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Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.
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| 51 | 2021-02-25 | pain in extremity, pain |
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea...
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Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
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| 51 | 2021-02-28 | pain |
3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other...
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3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 22Jan2021 at 09:00 (at the age of 51-years-old) as a single dose in the left arm for COVID-19. The patient had no medical history. She was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient received another unspecified vaccine on 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously took penicillin from an unspecified date for an unspecified indication and experienced allergy. On 23Jan2021 at 06:00, the patient experienced 3 days of body pain and muscle aches all over body and face. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of 3 days of body pain and muscle aches all over body and face was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 51 | 2021-02-28 | pain in extremity, vertigo, dizziness |
Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Numb...
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Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
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| 51 | 2021-03-02 | pain in extremity |
Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a ...
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Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiration date was not reported), via an unspecified route of administration on the left arm on 30Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Sulfa allergy, penicillin allergy, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol. The patient experienced fever over 100, headache, chills, joint soreness and arm soreness on 31Jan2021 at 04:00 am. No treatment was given in response to the events. Outcome of the events was unknown.
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| 51 | 2021-03-02 | pain in extremity |
I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administratio...
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I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: "Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days." The patient was not treated for the events. The outcome of the events was recovered.
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| 51 | 2021-03-02 | pain in extremity |
Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A ...
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Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for covid-19 immunization. The patient's medical history included Environmental allergies: some trees and grass. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), colecalciferol (VITAMIN D [COLECALCIFEROL]), all for unspecified indication. The previously took her first dose of bnt162b2 on 07Jan2021 (lot number: EL3248) on her left arm for covid-19 immunization. On 28Jan2021 at 17:30, the patient experienced Left arm soreness beginning a few hours after vaccine administration and lasting about another 24 hours. The outcome of the event was recovered on an unspecified date. The seriousness of the event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
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| 51 | 2021-03-02 | pain in extremity |
just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contact...
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just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3249; expiration date: unknown) at vaccination age of 51-year-old intramuscular in the right arm on 15Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included high blood pressure, and allergies to penicillin and sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included unspecified medication. The patient received her most recent COVID-19 in a public health clinic/veterans administration facility. The patient reported that she did no adverse events, she was just a sore arm starting approximately 6 hours after injection (15Jan2021) and lasting about 24 hours (16Jan2021). The event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 16Jan2021. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
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| 51 | 2021-03-07 | pain |
Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient)...
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Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 02Feb2021 08:30 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included allergies to macadamia nuts. There were no concomitant medications. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (brand=Pfizer) on 14Jan2021 07:30 AM (vaccine location= left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced fever, aches and pains, headache on 03Feb2021 05:00 AM. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 51 | 2021-03-18 | numbness, feeling hot, pain in extremity, tingling |
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu...
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Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
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| 51 | 2021-03-21 | dizziness | c/o of dizziness after the vaccine was administered |
| 51 | 2021-03-21 | dizziness | c/o of dizziness after vaccination during the post vaccine observation period. |
| 51 | 2021-03-22 | dizziness |
Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/2...
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Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/21
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| 52 | 2020-12-31 | numbness |
10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ...
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10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY. NO PARLYSIS WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM
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| 52 | 2020-12-31 | dizziness, speech disorder |
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr...
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Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
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| 52 | 2021-01-01 | pain |
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2...
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12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.
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| 52 | 2021-01-03 | facial paralysis |
52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial dr...
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52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.
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| 52 | 2021-01-03 | pain in extremity | Arm pain, extreme fatigue, muscle spasm (charley horse) in left inner thigh, shin and foot. |
| 52 | 2021-01-03 | pain in extremity | Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face) |
| 52 | 2021-01-03 | dizziness, pain in extremity |
Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The...
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Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The morning of the 26th (day 3 after vaccine) , I woke up and felt great.. I took my normal 4- 5 mile run. I felt a little dizzy , & hungry when I ran (not my normal) , got home had diarrhea 1 x , then for next two days very faint GI discomfort and I had fever for two days , temp range 99-100
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| 52 | 2021-01-03 | difficulty speaking |
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b...
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Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
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| 52 | 2021-01-03 | pain |
injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ank...
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injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ankle cough
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| 52 | 2021-01-04 | pain, feeling hot, dizziness |
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received...
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1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.
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| 52 | 2021-01-04 | numbness |
About a half hour after receiving the vaccine I started feeling a numbness under my right eye that p...
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About a half hour after receiving the vaccine I started feeling a numbness under my right eye that progressed slowly progressed to around my right eye, cheek, ear and upper right side of my teeth. I was able to move my muscles (no crooked smile) and close my eyes completely. Today I still have this strange feeling but it's very subtle. This hasn't worsened at all since yesterday but hasn't gone away either.
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| 52 | 2021-01-04 | dizziness |
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and c...
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Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
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| 52 | 2021-01-04 | weakness |
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov...
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Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
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| 52 | 2021-01-04 | facial paralysis |
Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female pati...
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Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 17Dec2020 at 14:30 (at the age of 52-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no other medications within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfamethoxazole, trimethoprim (SEPTRA) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced droopy left cheek on 21Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of droopy left cheek was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of droopy left cheek might not be excluded considering the plausible temporal relationship. The patient had previous allergy reaction to antibiotic (sulfamethoxazole, trimethoprim) use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-04 | dizziness, pain in extremity | Nausea, lightheadedness, headache, fatigue, sore/swollen arm |
| 52 | 2021-01-04 | feeling hot |
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe...
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Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
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| 52 | 2021-01-04 | pain |
chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a c...
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chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious. Information about lot/batch number has been requested.
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| 52 | 2021-01-04 | tingling, numbness |
intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and...
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intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.
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| 52 | 2021-01-05 | dizziness |
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ...
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Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
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| 52 | 2021-01-05 | pain |
Fever of 103 F two nights in a row. Aches as bad as when I had Covid-19 in October. Shortness of bre...
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Fever of 103 F two nights in a row. Aches as bad as when I had Covid-19 in October. Shortness of breath. Fatigue.
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| 52 | 2021-01-05 | pain | Fever, body aches, severe headaches, the vaccine site is hot and swollen and painful |
| 52 | 2021-01-05 | weakness |
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ...
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Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
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| 52 | 2021-01-05 | pain |
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n...
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Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
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| 52 | 2021-01-05 | pain in extremity |
Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (p...
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Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.
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| 52 | 2021-01-05 | tremor, numbness, tingling, dizziness |
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p...
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Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
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| 52 | 2021-01-05 | dizziness |
PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PA...
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PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PALPATIONS, AND APPEARED PALE. CLIENT STATED HISTORY OF LOW BLOOD PRESSURE. BLOOD PRESSURE TAKEN ABOUT 1420. 120/90. EMT NOTIFIED THAT THEY MAYBE NEEDED. EPINEPHRINE BROUGHT TO CAR. ENCOURAGED CLIENT TO TAKE SLOW, DEEP BREATHS. AFTER 10 MINUTES, STATED FELT MUCH BETTER. PARKING ATTENDANT STATED CLIENT'S COLOR HAD RETURNED. ENCOURAGED TO WAIT FOR ANOTHER 10 MINUTES BEFORE DRIVING AWAY.
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| 52 | 2021-01-05 | tingling |
Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on star...
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Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on starting 12/24/20. Fatigue and chills 12/28/20. Occasional right back tingling resolved 12/31/20.
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| 52 | 2021-01-05 | pain in extremity, pain |
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t...
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the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-06 | pain in extremity |
12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. H...
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12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER. Frequent PVCs; occasionally over the years. Discharged home. Not sure if related to vaccine as under a lot of stress.
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| 52 | 2021-01-06 | numbness |
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was t...
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Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.
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| 52 | 2021-01-06 | pain | Body aches Chills Fever of 101.3 F Joint pain Headache Dry cough |
| 52 | 2021-01-06 | numbness | Diarrhea numbness of face/tongue Narrative: |
| 52 | 2021-01-06 | dizziness |
Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B...
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Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
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| 52 | 2021-01-06 | pain |
Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin wit...
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Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin with some relief.
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| 52 | 2021-01-06 | pain | Temp 101, Oral Chills, body aches. |
| 52 | 2021-01-06 | dizziness, weakness |
Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest...
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Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6
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| 52 | 2021-01-07 | pain in extremity |
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i...
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12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
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| 52 | 2021-01-07 | numbness |
After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mout...
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After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.
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| 52 | 2021-01-07 | dizziness |
C/O: DIZZINESS. 1140: VS: 184/98, P: 92; 02 SAT: RA: 98%; 1152: VS: 167/88, P: 70; 02 SAT:...
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C/O: DIZZINESS. 1140: VS: 184/98, P: 92; 02 SAT: RA: 98%; 1152: VS: 167/88, P: 70; 02 SAT: RA: 98%
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| 52 | 2021-01-07 | weakness | Chills, vomiting, fever 104, upset stomach, low energy level, headache |
| 52 | 2021-01-07 | feeling cold, tremor |
Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer ...
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Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231, Expiration Date: 30Apr2021), via an unspecified route of administration in left arm, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure. The patient had unspecified concomitant medications. The patient took this shot on 31Dec2020 at her job at medical center (EDF, environmental service; it's housekeeping). The patient was fine during the daytime. The patient made it to her home and now she got the chills and was shaking on an unspecified date. When the patient was asleep, that is when she started feeling chills and the shake. The patient was bad and cold, and she got a bad chill. The patient wanted to report and asked if it was going to go away. No treatment was administered for the events. The outcome of the events was unknown.
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| 52 | 2021-01-07 | dizziness, pain |
Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep ear...
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Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep early due to fatigue. Woke up not feeling well: headache, body aches, dizzy. Unable to go to work that day. By Tuesday able to return to work though experiencing loose stools.
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| 52 | 2021-01-07 | pain | Fever 101.5, aches, chills, headache |
| 52 | 2021-01-07 | dizziness |
First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and h...
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First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and head feeling "fuzzy". Had patient drink water and juice. VS were BP 137/90 HR 91. She stated her HR routinely runs in the 90s. Observed her for greater than 30 minutes. Symptoms didn't worsen. She was awake, alert with a steady gait. Patient was released to home.
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| 52 | 2021-01-07 | dizziness | General Malaise, Light Headed, Palpitations & Nausea |
| 52 | 2021-01-07 | weakness |
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE...
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HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
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| 52 | 2021-01-07 | weakness | LEFT AXILLARY PAIN AND EDEMA, GENERALIZED WEAKNESS AND MUSCLE PAIN WAS UNABLE TO GET OUT OF BED |
| 52 | 2021-01-07 | pain | Low grade temp, chills, body aches, nausea and diarrhea, headache |
| 52 | 2021-01-07 | numbness | Mid back pain, Right hip numbness, macular rash on administered arm |
| 52 | 2021-01-07 | lightheadedness, dizziness, feeling hot |
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins ...
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Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
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| 52 | 2021-01-07 | feeling hot, weakness |
SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO...
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SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 52 | 2021-01-07 | feeling hot, pain in extremity, weakness |
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski...
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Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
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| 52 | 2021-01-07 | dizziness | c/o light headedness, ems evaled pt. declined further treatment. or eval symptoms resolved. |
| 52 | 2021-01-07 | dizziness |
dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This ...
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dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This is a spontaneous report from a non-contactable consumer, the patient. This 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration from 30Dec2020 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included depression from an unknown date and unknown if ongoing and dyslipidaemia from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram (CITALOPRAM) and atorvastatin (ATORVASTATIN). On 30Dec2020, the patient experienced dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat. The adverse events resulted in a doctor or clinic visit. Therapeutic measures included Tylenol and Nyquil. The clinical outcome of dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat was not resolved. It was also reported that since the vaccination, the patient was tested for COVID-19 on 04Jan2021 via nasal swab, results pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 52 | 2021-01-07 | pain |
fever 99.7; Body ache; Headache; This is a spontaneous report from a contactable nurse reported for ...
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fever 99.7; Body ache; Headache; This is a spontaneous report from a contactable nurse reported for self. This 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Jan2021 at single dose (LOT# EL1284) for covid-19 immunisation. The patient got vaccine yesterday (01Jan2021) and had a side effect. The patient had a fever 99.7, body ache, headache on 02Jan2021 and wanted to know if can take anything. Outcome of the events was unknown.
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| 52 | 2021-01-07 | tremor |
muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous r...
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muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous report from a contactable nurse (reporting for herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history was none. Concomitant medications were not reported. The patient started having like muscle spasming or twitching and like shaking a little bit like her muscles were weak on an unspecified date. Outcome of the events were unknown.
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| 52 | 2021-01-08 | pain |
Body aches, headache, shaking chills and fever (102.6). Treated with Tylenol, rest and fluids. Sympt...
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Body aches, headache, shaking chills and fever (102.6). Treated with Tylenol, rest and fluids. Symptoms lasted 60 hours.
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| 52 | 2021-01-08 | tingling |
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r...
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HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
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| 52 | 2021-01-08 | pain in extremity, pain in extremity | Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats |
| 52 | 2021-01-08 | dizziness |
Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was h...
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Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears
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| 52 | 2021-01-08 | dizziness, feeling hot |
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra...
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after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
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| 52 | 2021-01-09 | lethargy, dizziness |
1. Light headedness. Treated with extra fluids. Began 30 minutes after vaccine and lasted about 4...
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1. Light headedness. Treated with extra fluids. Began 30 minutes after vaccine and lasted about 4 hours. 2. Fatigue and lethargy. Treated with rest and fluids. Began 24 hours after vaccine. Duration 12 hours. 3. Nasal congestion. No treatment necessary. Began 24 hours after vaccine. Duration 4 days.
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| 52 | 2021-01-09 | pain, pain in extremity, dizziness, feeling hot |
Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night t...
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Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night that was 100.9 . Body aches, cold, headache, dizziness. Saturday ran fever off and on that never got above 100.9. Which broke Sunday am. Sunday just fatigue, sore arm that is warm to the touch, but not red.
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| 52 | 2021-01-09 | pain in extremity | Extreme fatigue, muscle aches, slight fever (99.0) and right arm soreness |
| 52 | 2021-01-09 | dizziness, pain |
Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding heada...
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Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding headache, nausea, lightheaded, fatigue and just feeling bad. Next day dizziness, fatigue, headache and body aches. Symptoms continued with some shortness of breath. Nyquil taken at approx 5-6pm. 3rd day woke up had dizzy spell fell on the floor. Still having some fatigue lightheadedness and nausea.
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| 52 | 2021-01-10 | dizziness |
30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and h...
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30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and headache, worsening over next 15 minutes, with skipped beats. Heart rate was 115 and decreased 93 with breathing exercises for relaxation. Blood pressure was steady at about 190/110 ( she states she stopped her blood pressure medication 3 days prior). she was taken to ED for further evaluation and treatment
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| 52 | 2021-01-10 | dizziness |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-10 | pain, tremor |
ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS...
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ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS. THEN I DEVELOPED A SLIGHT FEVER - 100-101 - BAD HEADACHE, MUSCLE ACHES, BODY ACHES. TOOK TYLENOL REGULARLY, FINALLY EXCEDRIN FOR HEADACHE AND ICE PACKS FOR BACK OF NECK AND FOREHEAD. DIBILATING FOR THE NEXT DAY, THEN FEVER BROKE AND FELT BACK TO NORMAL.
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| 52 | 2021-01-10 | weakness |
Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and ...
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Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and sleepy. Arms felt weak. Pain in the back of the neck. At 3:05pm, BP 155/88 HR=66 Temp 98.4F O2=95% Glucose=160. Patient reports taking Tylenol prior to receiving the vaccine. At 3:10pm, BP=148/95 HR=68, O2=95%. Patient was released from clinic at 3:17pm. Patient reports having similar symptoms following 1st dose of Pfizer Covid-19 vaccine occurring 1 hour after receiving the dose. Patient reports being very sleepy and fatigued. Fatigue lasted for 3 days. Per patient, symptoms resolved with Tylenol and rest.
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| 52 | 2021-01-10 | dizziness | Chills, muscle and joint pain, fever, headache, fatigue, light headed, difficulty concentrating |
| 52 | 2021-01-10 | pain |
Headache/Body Aches/chills/ fever of 100.9. Lasted approximately 6 hours. Symptoms were similar to w...
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Headache/Body Aches/chills/ fever of 100.9. Lasted approximately 6 hours. Symptoms were similar to when I had Covid.
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| 52 | 2021-01-10 | migraine |
Migraine headache began the next morning about 7am and increased as the day progressed including nau...
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Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
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| 52 | 2021-01-10 | pain in extremity |
One week after first vaccine, sudden onset - with no trauma or new medications or other known provoc...
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One week after first vaccine, sudden onset - with no trauma or new medications or other known provocation developed significant pain at tendons- bilateral symmetrical - hands, wrists, elbows, neck, hips, knees, bottoms of feet
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| 52 | 2021-01-10 | tremor, pain |
Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Start...
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Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Started 12 hours after second dose of covid vaccine. No reaction to first dose.
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| 52 | 2021-01-10 | pain, inability to speak |
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn...
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Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
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| 52 | 2021-01-10 | tingling | Went into the ED for bilateral hand and feet tingling. Worked up for possible Guillain Barre. |
| 52 | 2021-01-10 | pain in extremity |
sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination,...
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sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination, woke with fever, chills, rigors; took Tylenol and Benadryl and symptoms subsided after about 3 hours.
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| 52 | 2021-01-11 | tingling |
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye...
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Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
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| 52 | 2021-01-11 | pain |
Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at th...
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Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at the injection site; a low grade fever/ a fever of 101.0; chills; This is a spontaneous report from a contactable registered nurse (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration in the left biceps of her arm on 05Jan2021 07:15 at single dose for COVID-19 immunization. Medical history included positive on 19Dec2020 for the COVID virus. She had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported a side effect she experienced after having the shot. Afterward her arm was very sore. The patient got it at 7:15 am and it didn't feel the sore until about midway through the day (05Jan2021). This was at the injection site. When she got home she had chills and a low grade fever (05Jan2021) so she took Tylenol. The morning (06Jan2021) she woke up with headache and a fever of 101.0. She still had the muscle soreness, it was more at the administration site but there was some general all over the body soreness too. The patient explained she was positive on 19Dec2020 for the COVID virus and felt like these were the same symptoms she had with the virus. When asked about a seriousness criteria, she stated she reported that her fever improved with the Tylenol and she was feeling better now. The outcome of soreness at injection site was not recovered, of fever, headache was recovering, of the other events was unknown. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
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| 52 | 2021-01-11 | numbness |
Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving ...
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Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving home. Took 1 benadryl when I got home and all symptoms subsided approx 30 minutes later.
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| 52 | 2021-01-11 | feeling hot, feeling cold |
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated sh...
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Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
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| 52 | 2021-01-11 | pain, tingling |
injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp ti...
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injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp tingling/burning over the medial clavicle and extending into the neck. there was no rash, redness, swelling, swallowing or breathing difficulty. At 21 days, I am still experiencing hyperaesthesia and some tingling over the medial clavicle, and a zinging sensation over the clavicle/sternoclavicular joint with L shoulder movement, valsalva or burping. evaluation on site by vaccine provider. telephone consultation with PCP 2 days and 1 week later, and brief telephone consultation with local allergist. gabapentin for discomfort
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| 52 | 2021-01-11 | pain |
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ...
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injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
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| 52 | 2021-01-12 | numbness |
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Use...
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At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
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| 52 | 2021-01-12 | dizziness |
Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Obse...
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Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Observed, issues resolved at 12:46 pm/
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| 52 | 2021-01-12 | pain | Insomnia, headache, fever, aches, skin pain |
| 52 | 2021-01-12 | pain in extremity |
Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild ...
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Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild headache.
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| 52 | 2021-01-12 | dizziness | developed headache, light headedness, nausea and fatigue |
| 52 | 2021-01-12 | dizziness | dizziness with perceived palpitations; facial flushing and headache |
| 52 | 2021-01-13 | pain |
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel...
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About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
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| 52 | 2021-01-13 | pain in extremity, pain, dizziness |
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/...
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Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
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| 52 | 2021-01-13 | dizziness |
Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain...
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Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain; Sudden head rush; This is a spontaneous report from a two contactable Other Health Professional (one of which patient) received via Medical Information Team. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), via an unspecified route of administration in arm left on 30Dec2020 at single dose for COVID-19 immunization. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine at 10 mg and rosuvastatin calcium at 20 mg, both from an unknown date and ongoing. The patient experienced headaches, dizziness, loose stool, upper back pain where the lungs are/upper back pain, all on 02Jan2021. The patient also experienced loose bowels on 03Jan2021 and sudden head rush on 30Dec2020. The patient underwent lab tests and procedures which included COVID-19 test which resulted negative on 06Jan2021. The patient outcome of headache, dizziness, loose bowels was recovering, the outcome of loose stools was unknown, the outcome of back pain and sudden head rush was recovered.
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| 52 | 2021-01-13 | pain |
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu...
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Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
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| 52 | 2021-01-13 | dizziness | None stated. |
| 52 | 2021-01-13 | pain in extremity, numbness |
PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on ...
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PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on injection side. Face /cheek feels sore, swollen and numb- coming from neck, into face, up to temple/forehand, into cheek and jawline. Is this possible Bells Palsy ?
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| 52 | 2021-01-13 | pain, pain in extremity |
Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle a...
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Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle ache, head ache, fatigue, and arm pain.
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| 52 | 2021-01-13 | numbness |
Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness....
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Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness. I was worked up in the ER for a possible stroke but all testing was negative. The numbness lasted 3 days and has now resolved. My COVID shot was given in the right arm.
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| 52 | 2021-01-13 | pain |
headache; high fever; chills, shivering; body ache; This is a spontaneous report from a non-contacta...
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headache; high fever; chills, shivering; body ache; This is a spontaneous report from a non-contactable Other HCP reporting for herself. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number K9231), intramuscular, in left arm, on 06Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 52 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and did not receive concomitant medications. She had no known allergies to medications, food, or other products. On the first and second day the patient experienced high fever, chills, shivering, body ache; headache the third day with chills. No treatment was given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The events were resolving. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-01-14 | difficulty speaking |
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ...
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1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
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| 52 | 2021-01-14 | tingling |
23 minutes after the patient receive the shot she complained of tingling at the site and down her ar...
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23 minutes after the patient receive the shot she complained of tingling at the site and down her arm. Provided patient with 2 25mg Benadryl to self administer. Upon checking at 1pm and 7:00pm patient was feeling better.
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| 52 | 2021-01-14 | dizziness, tingling |
About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of...
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About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm. Vital signs within normal limits. Patient improved.
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| 52 | 2021-01-14 | pain |
About 14 hours after my 2nd dose I experienced headache, fever, chills, body aches for about 12 hour...
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About 14 hours after my 2nd dose I experienced headache, fever, chills, body aches for about 12 hours; What is concerning is that my Vsafe app asked if I received the 2nd dose and then never checked back for side effects. This is when most people are experiencing side effects and the monitoring parameters that are set forth by the CDC are failing
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| 52 | 2021-01-14 | vertigo |
After the injection, I experienced vertigo. I did a telemedicine with Dr. and I also saw another Dr....
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After the injection, I experienced vertigo. I did a telemedicine with Dr. and I also saw another Dr. in her office.
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| 52 | 2021-01-14 | dizziness |
Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of ...
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Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of receiving vaccine, patient complained of lightheadedness. Vital signs showed slight hypotension which improved with hydration.
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| 52 | 2021-01-14 | pain |
Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision re...
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Blurred vision, Generalized body aches. Treatment- Ibuprofen and Tylenol. Outcome: blurred vision resolved, no improvement in generalized body aches.
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| 52 | 2021-01-14 | vertigo | I experienced vertigo on 01-15-2021. |
| 52 | 2021-01-14 | pain |
I got my 2nd dose on Wednesday and felt fine all night. On Thursday, I started to have a low grade ...
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I got my 2nd dose on Wednesday and felt fine all night. On Thursday, I started to have a low grade fever with body aches and tiredness. On Thursday night about 6pm, I developed severe swelling under my left arm and down the left side of my ribs.
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| 52 | 2021-01-14 | pain |
Localiized pain started on 1/13/21 Left arm induration of 5-10cm started on 1/14/21 at noon time Le...
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Localiized pain started on 1/13/21 Left arm induration of 5-10cm started on 1/14/21 at noon time Left arm induration of 15-20cm noted 1/15/21 at 8am
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| 52 | 2021-01-14 | vertigo, pain in extremity, pain |
Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge b...
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Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge bump on her face that is very painful; she cannot walk straight or without assistance anymore; Vertigo; Weakness in the muscles; a little arm soreness; Body aches; Chills; Could not sleep; Fever; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), Batch/lot number: EK9231, Expiry Date: 31Mar2021, via an unspecified route of administration on 06Jan2021 09:00 at single dose in deltoid right for COVID-19 immunisation. Medical history included heart attack from Jul2019. Concomitant medication included diltiazem from 2019 and ongoing at 120mg tablet taken daily for abnormal heart rhythm she did not know of until had heart attack, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing at 81 mg tablet taken daily for heart attack. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation; she got the Flu vaccine every year and got shingles vaccine in Mar2020 for immunization. She did totally fine after receiving Flu vaccines and the Shingles vaccine. She had no side effects from the Flu vaccines except maybe a little arm soreness; she had arm soreness for a couple of days after the shingles vaccine; maybe a slight fever and took it easy. This Emergency Room Nurse (patient) received her second dose of Pfizer BioNTech COVID-19 Vaccine on 06Jan2021 around 9:00am. She went back to work, worked around 6-8 more hours that day and was fine. She went home and around 8-10 hours after she got the second dose on the evening of 06Jan2021 she had a little arm soreness and body aches. Last night all night she had chills; she could not sleep; fever. This morning: 07Jan2021 she was so nauseous that she got up and tried to get to the bathroom where she threw up a little. She reported as of 07Jan2021 she kept falling down: She fell in the bathroom this morning first when she was trying to get to the bathroom to throw up; During the second fall she was going on the stairs and fell, and hit her head; she had a huge bump on her face that was very painful now that she thought was from that second fall; and she had the third fall this evening; she cannot walk straight or without assistance anymore, she had been on the couch all day. She has had vertigo all day and weakness in the muscles. Chills was described as unbearable, heavy chills that she could not control. Fever: Temperature of 102-102.4 degrees Fahrenheit. The high fever hit around 3:00am on 07Jan2021. When her high fever hit around 3:00am she thought she would go to the emergency room but she did not want to scare her family so she stayed home and tried to pull through it. Today she took a Tylenol after she threw up this morning just to get through the day. Since she cannot walk without assistance or walk straight today that's the only lingering symptom that really worries her; she may go to the emergency room tonight if she did not get any better. She just did not want to scare her family and the emergency room was another copay cost so she really did not want to go to the emergency room at her workplace; but she may go there tonight and be kept overnight under observation. Prior to taking this second dose of Pfizer BioNTech COVID-19 Vaccine she was completely fine. She expected to have body aches, chills and fever; but she never thought the Pfizer BioNTech COVID-19 Vaccine would put her into a place where she is falling like this with the nausea and vertigo; she has never in her life had vertigo or falling like this. She reported she had no other vaccinations on the same date as Pfizer BioNTech Vaccine second dose. Has had no other vaccines in the recent past. She had never felt like this before with any other vaccines; she had never felt so weak in her muscles and never fallen down like this with any other vaccines. Seriousness criteria and outcome of all events unknown. The reporter considered all events were related to Pfizer BioNTech COVID-19 Vaccine.
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| 52 | 2021-01-14 | unresponsive to stimuli |
THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD ...
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THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.
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| 52 | 2021-01-14 | pain in extremity |
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f...
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Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
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| 52 | 2021-01-14 | dizziness | light headed, fever, nausea, head ache, trouble breathing |
| 52 | 2021-01-14 | pain in extremity |
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder a...
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neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
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| 52 | 2021-01-14 | pain in extremity | onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52 |
| 52 | 2021-01-15 | dizziness, tingling |
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ...
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11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
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| 52 | 2021-01-16 | pain |
Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache las...
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Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache lasted 3 days , chills intermittent for several days fatigue still have
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| 52 | 2021-01-17 | pain, tenderness |
Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness u...
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Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness under arm/side of breast.
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| 52 | 2021-01-17 | pain |
Symptoms started at 3:00 AM on 01/05/2021, complains of headache, body aches, temp 100.4, congeston,...
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Symptoms started at 3:00 AM on 01/05/2021, complains of headache, body aches, temp 100.4, congeston, fatigue. Took Tylenol for fever.
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| 52 | 2021-01-18 | numbness, pain in extremity |
Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side...
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Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
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| 52 | 2021-01-19 | pain | 99.9 fever. body aches. Joint pain. Headache, nausea, fatigue |
| 52 | 2021-01-19 | dizziness |
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed ...
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Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek. Patient was tachycardic and hypertensive; taken to ER for observation. Received a dose of oral diphenhydramine 50 mg. Was ultimately discharged home in stable condition.
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| 52 | 2021-01-19 | pain |
Began experiencing body aches, extreme fatigue and joint pain shortly after receiving first dose of ...
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Began experiencing body aches, extreme fatigue and joint pain shortly after receiving first dose of the vaccine. Taking OTC tylenol/motrin. Joint pain has resolved. Body aches and extreme fatigue remain.
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| 52 | 2021-01-19 | dizziness, feeling cold | DIZZY, CHILLS, FATIGUE |
| 52 | 2021-01-19 | vertigo |
Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to...
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Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to pick head up off pillow for 2 days. Unable to eat or drink as well.
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| 52 | 2021-01-19 | dizziness |
Patient reported feeling unwell, dizzy, dry heaving. Patient was watched monitored and charge RN wa...
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Patient reported feeling unwell, dizzy, dry heaving. Patient was watched monitored and charge RN was notified. No additional intervention.
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| 52 | 2021-01-19 | pain |
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE...
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RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
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| 52 | 2021-01-21 | pain |
2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from ...
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2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from the top of the shoulder to occasionally near the back shoulder blade. Range of motion is affected as it is painful to reach backwards or straight out laterally. Taking 800 mg of Ibuprofen every 6-8 hours to help ease burning sensation. Not always completely helps.
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| 52 | 2021-01-21 | pain |
Fever/chills /body aches Fatigue /headache Feel like lightning goes throughout my body Muscles and ...
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Fever/chills /body aches Fatigue /headache Feel like lightning goes throughout my body Muscles and bones extreme pain Extremely thirsty Couldn?t walk properly because of fatigue
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| 52 | 2021-01-21 | swollen extremities |
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATI...
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GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
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| 52 | 2021-01-21 | weakness |
Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Aro...
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Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Around 3 am, I awoke with chills and low grade fever. Tmax 103.8F, chills, pressure headache, neck/back pain, and fatigue that lasted ~30 hours. Still have mild pressure headache with mild back/neck pain and weakness.
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| 52 | 2021-01-21 | pain |
after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day...
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after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day and felt like it came and went very quickly. the injection site was still hard and edematous after about 2 weeks. After the second vaccine I became slightly achy the same day I got the shot but pre-emptively took ibuprofen, which worked well. it wasn't until the day after my shot (towards the end of my work day) that I became incredibly fatigued and muscles ached. Later in the evening I developed a sore throat and slight cough, I did not take my temperature but felt I had a slight temperature increase. the 2nd and 3rd day post shot I was incredibly fatigued with a slight sore throat. by 4th day post shot I was feeling back to my normal self.
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| 52 | 2021-01-21 | pain |
hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. ...
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hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. Itching. later feeling fatigue, body aches and headache.
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| 52 | 2021-01-21 | tingling, numbness |
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my ...
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immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days. The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
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| 52 | 2021-01-22 | tingling |
paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten...
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paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten worse - just a mild tingling sensation) - no pain
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| 52 | 2021-01-24 | feeling hot |
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ...
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My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
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| 52 | 2021-01-24 | pain in extremity |
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ...
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Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
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| 52 | 2021-01-24 | dizziness | Reported blurry vision, dizziness, and severe headache. |
| 52 | 2021-01-24 | tremor |
Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Musc...
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Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Muscle aches; Fever finally broke at 3pm on the next day 17 hours after symptoms began; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 09Jan2021 at 11:00, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 22Dec2020 at 11:00 for COVID-19 immunization. On 09Jan2021, the patient had shot at 11am with no reaction then at 10pm when started shaking/shivering violently for 2 hours and then developed very bad headache, muscle aches. The patient's fever up to 101 then the fever finally broke at 3pm on the next day (10Jan2021) 17 hours after symptoms began. As treatment, patient took Tylenol and Excedrin for headache, muscles aches and fever. No treatment was reported for the events shaking/shivering. The outcome of the event fever was recovered on 10Jan2021 15:00 while the rest of the events was recovered on Jan2021.
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| 52 | 2021-01-24 | numbness | Systemic: Other- numbness/tingling of face and throat and neck; symptoms lasted 1 day |
| 52 | 2021-01-24 | pain, pain in extremity |
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provide...
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Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back. After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21. The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt. Woke again at 8:00am with fever of 101.3 and the same symptoms. Alternated Tylenol and Ibuprofen every 2 yours. Fever went away around 10:00am but went still had body and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit. Still have body & skin aches. I am tired and I feel slightly off. My eyes are very tired.
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| 52 | 2021-01-24 | pain | body aches, low grade fever - total duration approx 36 hrs |
| 52 | 2021-01-24 | pain |
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue...
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fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 52 | 2021-01-24 | pain | headache, fever, chills, body aches, nausea |
| 52 | 2021-01-25 | dizziness |
At 11:55 pm, Covid-19 vaccine administered to client. 11:57 am, client escorted to vaccination obser...
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At 11:55 pm, Covid-19 vaccine administered to client. 11:57 am, client escorted to vaccination observation room. 12:01 pm Client asked observer "Is it normal to feel light headed?"; Observer had client lie on the floor and elevate her legs; Observer radios for assistance 12:02 pm Assistance of RN arrived in the room. 12:03 pm Observer monitored B/P 146/98, pulse 66 Skin color good. Client verbalizing coherently. 12:05 pm Pulse oximeter applied 97%, pulse 77 12:10 pm B/P 122/66, pulse 84 Oximeter 97% 12:15 pm B/P 124/66 pulse 78, oximeter 97% Client assisted to sitting position. 12:27 pm B/P 124/66, pulse 78, oximeter 97% 12:30 pm Client release from clinic. Escorted to first floor and client then left the building.
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| 52 | 2021-01-25 | pain, weakness |
had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous ...
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had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 52 | 2021-01-26 | dizziness |
11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light h...
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11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light headed had two masks on placed in private room so she could remove masks. 11:21 breathing better masks removed 11:35 b/p 130/90 heart rate 94 breathing easy. Informed to only wear one mask. Instructed to Call 911 for further breathing difficulty.
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| 52 | 2021-01-26 | dizziness |
Following first dose of COVID-19 vaccine patient stated that she felt "faint". Patient was given two...
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Following first dose of COVID-19 vaccine patient stated that she felt "faint". Patient was given two ice packs, juice and a private room to recover in.
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| 52 | 2021-01-26 | dizziness |
Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a ...
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Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED with RR
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| 52 | 2021-01-26 | pain |
States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tirednes...
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States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tiredness, body aches, feeling unwell. Calling for follow-up because it has been over 48 hours since the vaccine and she still has symptoms. Now having sinus pain and congestion. Advised to follow-up with PCP. Placed order for COVID. COVID test on 1/19/21 resulted negative.
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| 52 | 2021-01-26 | feeling hot, pain | Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing |
| 52 | 2021-01-26 | facial paralysis | facial droop Left |
| 52 | 2021-01-26 | pain | headache, body aches, sweats, fatigue |
| 52 | 2021-01-28 | pain, numbness, tingling |
1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c...
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1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c/o numbness and tingling in L arm where vaccine was administered with radiating pain to L shoulder, RN added 10 minutes to observation and educated patient to go to the nearest ER if symptoms aren't resolved 1/26/2021 09:08:07 AM > called to check on patient, message left
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| 52 | 2021-01-31 | migraine |
39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), di...
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39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.
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| 52 | 2021-01-31 | pain, weakness |
fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous ...
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fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 07Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included Meniere's disease, and allergies to Latex. The patient previously took cefalexin (KEFLEX) and codeine and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 17Dec2020 17:30 in the left arm for COVID-19 immunization. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. On 08Jan2021 03:00, about 10 hours post vaccine, the patient experienced fever between 103 to 103 f, severe body aches, fatigue, and generalized weakness which lasted until about 60 hours post vaccination. The patient has not undergone COVID testing post vaccination. The outcome of the events was recovered on 10Jan2021 15:30.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-02 | pain |
Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain;...
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Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-02-03 | pain |
tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVI...
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tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
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| 52 | 2021-02-04 | dizziness |
throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; ...
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throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; slightly lightheaded; mild headache; This is a spontaneous report from a contactable other health professional (patient). A 52-year-old female patient received first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration into left arm on 20Jan2021 13:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included allergies to shrimp and lobster, mild asthma and high blood pressure. Concomitant medication included diltiazem, benzoyl peroxide (BP), cetirizine hydrochloride (ZYRTEC), loratadine, paracetamol (TYLENOL) and vitamins. The patient had allergies to past blood pressure medications which included amlodipine besilate (NORVASC), irbesartan (AVAPRO) and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After taking first dose about 20 minutes on 20Jan2021 at 13:50 the patient felt slightly lightheaded and had mild headache, no real concern. Left observation area to go home after 45 minutes. No other symptoms at that point. Light headedness went away. While driving and running errands a few hours later the patient noticed her throat was getting somewhat tight, some swelling on 20Jan2021 at 16:30; this is similar to when she used to have shrimp/lobster allergic reactions. The patient took 1 tab of Benadryl before it got too bad and it subsided after about 30 min. No shortness of breath or any more symptoms so she went home and went to sleep after a few hours. She woke up and her throat had still some swelling. She called her doctor and she was recommended to take more allergy meds throught out the day and to report event to facility and to monitor. The swelling has not gone but much better. She was concerned about 2nd shot if it can be given where she was observed and monitored for a day. The patient recovered from slightly lightheaded on unspecified date. The outcome of headache was unknown and the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events throat tightness and throat swelling are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-07 | dizziness | complained of dizziness; refused to stay to be observed extra 15 minutes; no other problems. |
| 52 | 2021-02-11 | vertigo |
meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; T...
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meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 52 | 2021-02-14 | dizziness, pain in extremity, feeling cold, tremor |
At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; ...
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At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-21 | pain in extremity |
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Ap...
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02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
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| 52 | 2021-02-21 | pain |
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 s...
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16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)
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| 52 | 2021-02-21 | movement disorder |
Extreme lupus flare up, followed by complete debilitating period of about 1 hour. Husband found me ...
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Extreme lupus flare up, followed by complete debilitating period of about 1 hour. Husband found me with muscles fully relaxed to a point of him being concerned and started talking to me. I was conscious but felt too heavy to move at all. With effort I could move and answer coherently. It was as if I had melted on the couch buy was fully awake.................
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| 52 | 2021-02-22 | pain |
"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal...
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"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal heart rhythm on auscultation O2 sat 100% temp 36.8 . She expresses tingling to the tips of her fingers, left shoulder pain radiated to her neck. DR in urgent care immediately notified and arrived . EKG ordered "
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| 52 | 2021-02-22 | dizziness |
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w...
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I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
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| 52 | 2021-02-22 | dizziness, pain | Strong headache, in the left arm and all over the body. Nauseas Chills Dizziness |
| 52 | 2021-02-23 | pain |
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal...
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Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 52 | 2021-02-23 | pain in extremity | I exp fatigue, arm soreness, body ache and flare of Psoriasis lasting 48 hours, |
| 52 | 2021-02-23 | pain, vertigo |
fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was re...
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fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (left arm) from 16Jan2021 17:30 (05:30 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Keflex and sulfa from unspecified date. Patient is not pregnant. No other vaccine was given in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included botulinum toxin type a (BOTOX), and ibuprofen (MOTRIN) from an unspecified date for an unspecified indication (medications in two weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 02Dec2020 07:45 AM, Left arm. The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021. The patient experienced fever, body aches, mild vertigo on 17Jan2021 12:00. Treatment was not given. Outcome of the events was recovered in 2021. Information about lot/batch number has been requested.
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| 52 | 2021-02-24 | pain in extremity |
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ...
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Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
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| 52 | 2021-02-28 | pain, dizziness |
Increased pain with deep breaths; dizziness 6/10 and "different"; a sharp pain/Increased pain; This ...
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Increased pain with deep breaths; dizziness 6/10 and "different"; a sharp pain/Increased pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), intramuscular from 25Jan2021 16:00 at SINGLE DOSE in left arm for COVID-19 immunization. Medical history included allergic rhinitis, depression, hypertension, and lupus. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), bupropion, hydroxychloroquine, olmesartan, colecalciferol, folate sodium, magnesium, omega-3 fatty acids, pyridoxine hydrochloride, vitamin b12 nos, vitamin e nos (SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS]), curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient previously took codeine and experienced Known allergies, hives, itching, throat swells. The patient had first dose of BNT162B2 on 04Jan2021 15:15 at 52-years-old. It was reported that the patient experienced usual chest pressure related to lupus condition but after getting Covid vaccine it is now a on 25Jan2021 16:00, sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED (Emergency department) with RR. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included investigation: 6/10 on 25Jan2021, respiratory rate: unknown results on 25Jan2021. The outcome of the events was unknown.
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| 52 | 2021-03-01 | tingling |
Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still ...
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Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still here. I can't feel anything below my knees and have weekness in my hands. I can't walk and have difficulty moving my legs. Doctors are saying that they don't know if I will ever walk again.
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| 52 | 2021-03-02 | pain |
I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasm...
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I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that "I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 52 | 2021-03-04 | pain |
feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from...
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feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration (at the age of 52-years-old) on 01Feb2021 12:30 at a single dose in left arm for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Bactrim and clarithromycin and experienced allergies. The patient experienced feel tired/more tired, mind felt foggy, feel achy throughout body all on 01Feb2021 14:30 with outcome of recovering. The patient reported that "Approximately 1 hr (as reported) after receiving the vaccine, I started to feel tired, and my mind felt foggy. A few hours later, I began to feel achy throughout body and more tired. Next morning continued to feel achy but not as tired." No treatment received for the events. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.
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| 52 | 2021-03-04 | pain |
palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; ...
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palpitations; Soreness for 2.5 days; it is red and bruised/Redness; Swelling in the injection area; bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple; Warm to touch/feels hot to touch; She felt pain immediately from the injection; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 12Feb2021 at a single dose on right arm for COVID-19 vaccination. Medical history included history of reactions to vaccination (including swelling), cardiovascular disease and she had 3 stents placed in the last 3 years, ongoing coronary artery disease, small vessel disease, heart attack (when she was 50 years old. She has been having symptoms in the last could of years), blood pressure, angina, and high cholesterol. Concomitant medication included ticagrelor (BRILINTA) as blood thinner, ranolazine (RANOLAZINE EXTENDED RELEASE) for angina, rosuvastatin for high cholesterol, losartan for blood pressure, metoprolol to help her heart not work as hard, ezetimibe as cholesterol booster, and acetylsalicylic acid (ASPIRIN) as blood thinner. The patient experienced palpitations on an unspecified date which resulted in a recent hospitalization. The patient was reported to have taken the first dose of COVID-19 vaccine on 12Feb2021 and had soreness for 2.5 days since an unspecified date, then it resolved. She reported that she felt pain immediately from the injection on 12Feb2021 and some pain after the injection and she typically have reactions where she swells. On 20Feb2021, she developed a bruise at the injection site, and it was also warm to touch. The bruising was the size of a half dollar and it was hot to touch. She stated that the bruising was purple, and she never experienced that before. She wanted to know if this could be due to the vaccine. on 12Feb2021. On 21Feb2021, she had swelling in the injection area, it is red and bruised, and the bruising was about the size of a half dollar or a little bigger. The redness looked like it was a little less, but the bruising has been more prominent. She wanted to know if she should get the second dose on 05Mar2021, as scheduled, and if she does, will the reaction be worse? The patient underwent lab tests and procedures which included exploratory tests: which revealed small vessel disease on an unknown date. The outcome of the event "Soreness for 2.5 days" was recovered; "She felt pain immediately from the injection", "it is red and bruised/Redness" was recovering; and "bruise at the injection site/bruising is about the size of a half dollar or a little bigger/bruising was purple", "Warm to touch/feels hot to touch" and "Swelling in the injection area" was not recovered, and for palpitations was unknown.
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| 52 | 2021-03-06 | feeling hot |
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i...
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After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
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| 52 | 2021-03-15 | pain |
Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over he...
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Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over her shoulder and around her neck. Pain worsened during the day, went to ER, found to have positive troponins and subsequent ecg were abnormal. Echo was negative and angiogram showed no blocked arteries. Cardiologist diagnosed her with pericarditis
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| 52 | 2021-03-17 | dizziness |
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper...
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ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
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| 52 | 2021-03-21 | inability to speak, numbness | Left side facial numbness and speech difficulty |
| 53 | 2021-01-02 | tenderness |
I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nur...
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I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes. Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.
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| 53 | 2021-01-03 | balance disorder, vertigo |
After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, ...
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After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down. Few seconds later, my heart beat increased faster and faster, my neck turned red. I called for help, they gave me some apple juice to drink and talked to me. About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color. I only had a little vertigo symptom but I was able to manage myself. About 2 hours later, symptoms disappeared and I was back to my normal health
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| 53 | 2021-01-03 | dizziness, lightheadedness |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | tingling |
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongu...
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Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
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| 53 | 2021-01-03 | dizziness |
With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I st...
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With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I stood up. My lips began to swell. Was given 50 mg Benadryl PO and watched for one hour. Never had difficulty breathing. Itchy continued for five days going away with Benadryl. Lymph nodes in arm pit of arm vaccine was in swelled and hurt for two days. Spiked a fever the second day twice that was controlled with Tylenol.
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| 53 | 2021-01-03 | tremor |
pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 ...
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pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.
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| 53 | 2021-01-04 | dizziness | Dizzy, altered, stridor. No oral swelling observed. |
| 53 | 2021-01-04 | dizziness | Headache, nausea, light-headed. Mostly resolved after 30 minutes of observation. |
| 53 | 2021-01-04 | feeling hot |
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l...
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Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
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| 53 | 2021-01-04 | numbness, tingling | Numbness and tingling in fingers and hand of same arm the vaccine was given in. |
| 53 | 2021-01-04 | tremor |
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi...
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Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
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| 53 | 2021-01-04 | dizziness |
Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received firs...
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Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
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| 53 | 2021-01-04 | pain, weakness |
The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for ...
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The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for 2 days and on 12/20 feeling 100 ft walk was tired. Then on 12/21 started my exp body ache lasted 2 days. I spoke with my PCP and had a appt on 12/28. On 12/31 it felt as of my symptoms was subsiding. I started feeling better on 1/2/21. I missed 6 days of work.
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| 53 | 2021-01-04 | feeling hot |
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ...
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Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-04 | pain in extremity |
Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pr...
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Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension (HTN) and diabetes mellitus (DM). The patient has no known allergies. The patient had received unspecified other medications the patient received within 2 weeks of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very sore arm on 28Dec2020 12:00. Outcome of the event was not recovered. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The event was assessed as non-serious.
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| 53 | 2021-01-04 | pain in extremity |
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced s...
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a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
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| 53 | 2021-01-04 | tingling |
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th...
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feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
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| 53 | 2021-01-04 | pain | headache, low grade fever, body aches, nausea |
| 53 | 2021-01-04 | dizziness |
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena...
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heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 53 | 2021-01-05 | dizziness |
Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and releas...
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Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and released to home.
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| 53 | 2021-01-05 | pain |
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 m...
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FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
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| 53 | 2021-01-05 | dizziness | Fever Woozy Headache chills |
| 53 | 2021-01-05 | pain |
Fever since 5 hours after injection. Chills, body ache, headache Fever as high as 102.6 at morning o...
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Fever since 5 hours after injection. Chills, body ache, headache Fever as high as 102.6 at morning of the next day and 100.8 24 hours late
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| 53 | 2021-01-05 | pain in extremity |
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms...
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In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.
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| 53 | 2021-01-05 | pain in extremity |
Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you f...
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Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you feel cold; arm be sore from the shot; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home. Medical history included Blood pressure high. Concomitant medications included metoprolol for Blood pressure high, potassium. The patient had got her COVID-19 Vaccine yesterday (29Dec2020) and now (30Dec2020) she had a little muscle pain, guess from the arm. She got the shot in her muscle yesterday. Today (30Dec2020), spiked a little fever, and she got a little muscle pain, joint pain. She felt good, she just got little ache in the back. She took some Tylenol, it has all worked today. The patient also experienced "arm be sore from the shot". She got a little chill that's why she took the Tylenol. she had a little fever, she caught fever or felt like chills like when feel cold. Therapeutic measures were taken as a result of ache in the back, fever, and chills included Tylenol. The outcome of the events was unknown.
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| 53 | 2021-01-05 | dizziness |
PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTER...
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PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTERED AT 7:50AM. SYMPTOMS IMPROVED, BP 179/79 HR 114 AT 7:53AM. PATIENT REFUSED AMBULANCE OR FURTHER MEDICAL TX. STAFF MEMBER OBSERVED FOR AN HOUR UNTIL FAMILY ARRIVED.
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| 53 | 2021-01-05 | dizziness, weakness, pain |
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w...
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Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
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| 53 | 2021-01-05 | pain |
Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020...
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Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020. Arm at injections site red swollen, hot to touch and itchy.
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| 53 | 2021-01-05 | numbness |
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi...
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associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
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| 53 | 2021-01-06 | facial paralysis, numbness, tingling | Bells Palsy?left facial droop and left facial numb/tingling |
| 53 | 2021-01-06 | pain | Chilling and body aches |
| 53 | 2021-01-06 | weakness |
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se...
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Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
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| 53 | 2021-01-06 | weakness, dizziness |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-06 | pain |
Very achy and tired the following day. very tender at injection site for three days following inject...
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Very achy and tired the following day. very tender at injection site for three days following injection. Bruising at injection site.
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| 53 | 2021-01-06 | pain |
fever, headache, chills, body aches--alternating tylenol and Ibuprofen, rest, staying hydrated x 2...
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fever, headache, chills, body aches--alternating tylenol and Ibuprofen, rest, staying hydrated x 2 days
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| 53 | 2021-01-07 | restlessness |
1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with di...
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1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with dinner that evening anticipating some body aches (which i had for 24h after dose 1). 1/7/21: Woke in the early AM with severe arthralgia, myalgia, restlessness, mild R arm swelling. Ate a small snack and took ibuprofen. All day 1/7/21: fatigue, myalgia, arthralgia (all of my large and small joints, my long bones, my intercostals, my large muscles stiff/ ached), and increasingly swollen R axillary lymph node(s) about the size of a large egg, extending into my upper chest. Food aversion at breakfast - could not tolerate eating more than a few bites. Slept almost all day except to re-dose ibuprofen and take a warm shower. Tolerating bland diet by evening. Tmax 99.3F forehead As of now 10:30am 1/8/21, myalgias are improving. Fatigue continues but is less. R axillary and chest lymph nodes are painful and swollen, up into my lower neck. Continuing to take ibuprofen with some food 3x per day
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| 53 | 2021-01-07 | dizziness |
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat...
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After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% Â At 1642, patient was discharged to family's care and taken home.
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| 53 | 2021-01-07 | tingling | Felt severe itching pins needles on arms, wrists, chest & neck. |
| 53 | 2021-01-07 | dizziness |
Headache and lightheadedness 15 min post vax Observation, fluids, food Sxs resolved after 10 mins of...
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Headache and lightheadedness 15 min post vax Observation, fluids, food Sxs resolved after 10 mins of close monitoring NKA
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| 53 | 2021-01-07 | feeling hot |
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I...
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My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
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| 53 | 2021-01-07 | pain in extremity |
Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities...
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Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities Narrative: developed bilateral leg pain, tightness of calf muscles within one hour of receiving vaccine. Headache on 12/23/2020
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| 53 | 2021-01-07 | pain |
Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fev...
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Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fever (Tmax 101.8). Last day of work and shift - ? supposed to work tonight but called off due to feeling ill Home remedies? - Tylenol at 0740 and sleep Any improvement? ? mild improvement Recommendation? EE educated to continue to monitor symptoms and call vaccine support with further concerns or questions. EE educated of changes in RedCap Survey and educated will need to be fever free for 24 hours before returning to work. EE reports she called off of work tonight as she is not feeling well. EE educated to continue to manage her symptoms and to follow the guidelines outlined in the TCH Illness in the Workplace Policy. EE denied COVID-19 exposure without proper PPE and denied travel. EE verbalized back understanding and denied further questions at this time.
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| 53 | 2021-01-07 | pain in extremity | chills, nausea, arm sore |
| 53 | 2021-01-07 | feeling cold, tremor, pain |
felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; ...
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felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.
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| 53 | 2021-01-07 | tremor |
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s...
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neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-08 | pain, weakness |
12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before...
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12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before fever was back to normal. Still have fatigue and weakness
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| 53 | 2021-01-08 | pain | at 12 hours post vaccine I had Headeaches and Body Aches for the next 20 hours |
| 53 | 2021-01-09 | feeling cold, pain | Fever Chills Aches Fatigue |
| 53 | 2021-01-09 | dizziness, pain in extremity, pain |
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midn...
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Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
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| 53 | 2021-01-10 | weakness, pain |
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever...
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1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
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| 53 | 2021-01-10 | pain, lethargy |
5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temper...
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5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temperature up to 101.5. On 1/8, temperature resolved, still bodyaches. On 1/9, symptoms resolving, but at 12:00pm temperature of 99.9 and fatigue. On 1/10 right deltoid where vaccine was administered, sight is warm to touch and swollen, painful.
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| 53 | 2021-01-10 | pain in extremity |
90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm...
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90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm weakness. she could not lift her arm above her head. she then developed severe dull, aching pain. the pain became sharp with movement. she could not sleep because of the pain. no redness or edema at the injection site. she is slowly regaining strength and range of motion in the arm, however the pain still remains and full strength has not returned.
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| 53 | 2021-01-10 | tingling |
A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have ...
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A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have had Bell's Palsy in the past (30 years ago)
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| 53 | 2021-01-10 | pain | Body Aches, Headache, F - resolved 24 hrs |
| 53 | 2021-01-10 | pain | Body aches, chills, injection site soreness |
| 53 | 2021-01-10 | weakness, tremor | Chills and shakes without fever, weakness, and headache |
| 53 | 2021-01-10 | pain, dizziness |
Fever 101, chills, H/A , tiredness, lower back pain, body aches. Felt slightly dizzy at times. Star...
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Fever 101, chills, H/A , tiredness, lower back pain, body aches. Felt slightly dizzy at times. Started 1/7/21 @2220. Slept most of 1/8. Medicated with Advil every 4-6 hrs for fever. Continued until 1/9/21 at 0100. Woke with H/A am 1/9 but no fever. Took last Advil for it.
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| 53 | 2021-01-10 | pain in extremity |
Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old fem...
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Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, intramuscularly in the left arm on 04Jan2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included an allergy to sulfa, from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 04Jan2021 at 09:45 the patient experienced left arm pain. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain was unknown.
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| 53 | 2021-01-10 | numbness |
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red...
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Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 53 | 2021-01-10 | tremor |
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno...
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Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
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| 53 | 2021-01-10 | lightheadedness, dizziness |
chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had n...
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chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 53 | 2021-01-10 | pain in extremity, tenderness | soreness in arm, not just to the touch, but hard to lift arm the next day. Better after day 2. |
| 53 | 2021-01-11 | pain | 100.6 temp body ached |
| 53 | 2021-01-11 | pain in extremity, lightheadedness |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | dizziness, pain in extremity |
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa...
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Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
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| 53 | 2021-01-11 | pain in extremity | Fatigue, sleepiness, pain on left arm |
| 53 | 2021-01-11 | tingling |
Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throug...
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Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throughout body but especially extremities. Occurred within the 5-15 min observation period. I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms. It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity. The sensation reminded me of the systemic response when receiving a contrast IV dye. I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others. I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
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| 53 | 2021-01-11 | dizziness |
Nausea, lightheaded, dizziness and headache starting 10 mins after. Felt like she was going to faint...
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Nausea, lightheaded, dizziness and headache starting 10 mins after. Felt like she was going to faint. Also felt like she was developing a migraine. Improved after about 20 minutes.
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| 53 | 2021-01-11 | pain | Patient describes chills, later a fever of 101.2 and body aches. |
| 53 | 2021-01-11 | dizziness |
Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed f...
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Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed for 30 minute observation, at observation completion patient reports she was also feeling slightly dizzy and lightheaded, reports those symptoms were occurring intermittently throughout 30 minute wait. Patient offered oral fluids (water/juice), and to stay a little longer, patient refused, reports she is fine to go home. Patient left observation on her own.
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| 53 | 2021-01-11 | migraine |
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo...
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Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
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| 53 | 2021-01-11 | pain, pain in extremity, dizziness, feeling hot |
Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I start...
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Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I started feeling a pinch in my arm, then I started feeling warm and light headedness. Then they checked my bp and it was 149/93 . Then I had to stay for 30 mins, then I left to go home. I had body ache and a mild temperature. It was 98.2 .My arm is sore, and my joints and body hurts. I have a headache too , and I just took an ibprophen. I am still not feeling well. I did not go to the ER, hospital or doctors office about this ae.
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| 53 | 2021-01-11 | tingling, pain |
Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sens...
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Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
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| 53 | 2021-01-12 | dizziness |
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ...
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12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
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| 53 | 2021-01-12 | balance disorder |
12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressur...
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12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressure was 180/117 and husband took her to the hospital.
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| 53 | 2021-01-12 | dizziness |
@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), ...
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@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), 95-96% RA, rr 22, hr 84, temp of 97.2, Reports feeling dizzy and light headed. Patient has a history of allergies, swelling. @1004 repeat vitals 123/81y, 98% RA, hr 77, RR 21, denies pain, remains anxious and light headed. About 15 minutes later, she reports feeling better, less anxious, no more light headedness.
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| 53 | 2021-01-12 | pain |
After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea,...
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After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea, significant abdominal pain and abdominal cramping with nausea for 3 days, headache, body aches, fatigue. Unable to work . Injection site pain was minimal lasting 1 day.
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| 53 | 2021-01-12 | pain | Chills and Body aches |
| 53 | 2021-01-12 | pain | Chills fever body aches |
| 53 | 2021-01-12 | dizziness |
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo...
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Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
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| 53 | 2021-01-12 | pain | Fatigue, chills, nausea, throwing up, body aches - persisted 2 days after 2nd dose shot |
| 53 | 2021-01-12 | tremor |
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j...
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Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
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| 53 | 2021-01-12 | pain |
Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. ...
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Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. Next day 1/13/2021, flu like symtoms, felt feverish, sluggish, ache all over, felt better after 3PM in afternoon, but not 100% normal.
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| 53 | 2021-01-12 | dizziness, pain in extremity, vertigo |
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a co...
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anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-13 | pain |
1/11/2021 7pm whole body felt painful, chill, lower back pain, under armpit of injection side very p...
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1/11/2021 7pm whole body felt painful, chill, lower back pain, under armpit of injection side very painful. Not able to get up this morning. Took 1000mg Tylenol. Last time took Tylenol was 1 am this morning. Staff is worried. Please advise. exposed 1/1/2021 (daughter).
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| 53 | 2021-01-13 | migraine |
15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and...
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15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and muscle aches.
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| 53 | 2021-01-13 | feeling hot, pain |
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ...
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FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
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| 53 | 2021-01-13 | pain |
Felt very tired the evening of my 2nd dose of Covid vaccine. Woke early the next morning (01/08/21)...
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Felt very tired the evening of my 2nd dose of Covid vaccine. Woke early the next morning (01/08/21) with a high fever, chills, body aches, fatigue. Fever broke around midnight that night and I felt back to normal around noon the next day. Overall, I felt unwell for about 48 hours, and very sick for about 18 hours. I did not medicate for sx as we were advised by the hospital against NSAIDS to maximize antibody production.
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| 53 | 2021-01-13 | pain |
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on ...
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Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
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| 53 | 2021-01-13 | pain |
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body ...
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I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness. I took 2 Aleve before injection and Benadryl 25mg at 9p after injection.
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| 53 | 2021-01-13 | pain in extremity |
Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low ...
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Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low grade fever of 100 F; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female received bnt162b2 (lot: EK9231), intramuscular in the left arm on 30Dec2020 14:30 at a single dose for covid-19 immunization. The patient's medical history included migraine, seizure (resolved x2years) from an unknown date and unknown if ongoing , and allergy to penicillin. There were no concomitant medications. On 30Dec2020 20:00, the patient experienced left arm soreness for 24 hours and low grade fever of 100 f. The outcome of the event was recovered on an unknown date. No treatment was given to the patient for the event. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and has not been tested post vaccination.
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| 53 | 2021-01-13 | feeling hot |
Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a...
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Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a little bit of difficulty breathing. Symptoms except rash resolved after 30 minutes of observation. Patient discharged home from the vaccination clinic.
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| 53 | 2021-01-13 | dizziness, pain, tingling |
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig...
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Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
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| 53 | 2021-01-13 | pain |
Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest a...
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Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization. Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
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| 53 | 2021-01-13 | pain |
The side effects started early morning the day after the vaccine with body aches chills and tirednes...
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The side effects started early morning the day after the vaccine with body aches chills and tiredness and also a light headache. Very similar symptoms to COVID 19.
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| 53 | 2021-01-13 | weakness, dizziness, tremor |
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch...
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Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
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| 53 | 2021-01-13 | dizziness | dizzy, nauseous, tired that lasted 24 hours- missed a day of work |
| 53 | 2021-01-13 | pain | headache, chills, body ache |
| 53 | 2021-01-13 | migraine, pain | stomach issues, migraines. body aches Fatigue |
| 53 | 2021-01-14 | pain |
3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on ch...
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3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on chest, abdomen right trunk resolved within 6 hrs. 9:00 PM chills, body aches, nausea resolved within 48 hrs 1:50 AM. Diarrhea resolved within 12 hours 2:00 AM. Vomiting multiple times resolved within 30 minutes
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| 53 | 2021-01-14 | pain | Body aches, chills, fever 24 hours |
| 53 | 2021-01-14 | dizziness |
COVID Vaccine Clinic. Upon staff member receiving vaccination, collapsed after getting up from chai...
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COVID Vaccine Clinic. Upon staff member receiving vaccination, collapsed after getting up from chair. Rapid Response was called. Staff member was positioned supine with legs elevated. Blood pressure 147/88 HR 92.Po2 at 100% on room air. Complained of feeling faint and dizzy. Assessed by Rapid Response RM and MD. Escorted via cart to mid hallway for further evaluation. SM symptoms continued to be concerning, transported to ED with MD escort. Staff member was evaluated in ED. fluids given, Zofran for nausea and Benadryl. CTOH was completed and resulted as no abnormalities. Staff member was discharged to home in stable condition.
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| 53 | 2021-01-14 | pain |
Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot a...
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Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot about 1-3 inches below injection site; patient received the second dose in less than 21 days from the first dose; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ0142), intramuscular in the left arm on 05Jan2021 at 08:00 AM (at the age of 53-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 intramuscular on 19Dec2020 at 19:00 PM, lot number: EJ1685 at the age of 53-year-old for COVID-19 immunization in the left arm. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 05Jan2021 at 22:00 PM the patient experienced chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. The patient took Motrin for chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the chills, body ache, fatigue, redness and hot about 1-3 inches below injection site was not recovered.
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| 53 | 2021-01-14 | pain |
Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare pr...
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Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 07Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included depression. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient experienced chills, body ache, headache, insomnia on 08Jan2021 02:00. Outcome of the events was not recovered. No treatment was given for the adverse events. The reporter assessed the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information of lot/batch number has been requested.
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| 53 | 2021-01-14 | swollen extremities, numbness |
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ...
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Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
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| 53 | 2021-01-14 | pain |
Fatigue; fever; Chills; body aches; This is a spontaneous report from a contactable consumer (patien...
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Fatigue; fever; Chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient previously took 1st dose of BNT162B2 on an unknown date for COVID-19 immunization. There were no concomitant medications. The patient wanted to report a side effect of the Pfizer COVID vaccine. Stated that she had her second dose yesterday morning at 9am. Stated that she woke up this morning 08Jan2021 at 3am with fever, chills and body aches. The reporter is a nurse's aide in ICU COVID unit. Stated that she took acetaminophen (TYLENOL) and her fever resolved at 6am this morning. Stated that the chills resolved at 6am this morning. Stated that the fatigue started at 9am this morning. Outcome of the events fever and chills was recovered on 08Jan2021 at 06:00 while not recovered for the other events. Information on the Lot/Batch number has been requested.
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| 53 | 2021-01-14 | pain |
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ...
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Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
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| 53 | 2021-01-14 | pain |
aches; fever; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant f...
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aches; fever; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her most recent COVID-19 vaccine in a hospital. The patient experienced aches and fever on 07Jan2021 22:00. The outcome of the events was recovered in Jan2021. The reporter considered the events as non-serious. The patient received ibuprofen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Information on Lot/Batch number has been requested.
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| 53 | 2021-01-14 | tingling, pain |
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in...
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fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-14 | pain in extremity, tingling |
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan...
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shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 53 | 2021-01-15 | pain, weakness |
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very...
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Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
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| 53 | 2021-01-15 | tingling |
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min...
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Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
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| 53 | 2021-01-16 | pain, feeling cold | Fever, chills, achey, underarm pain. |
| 53 | 2021-01-16 | pain |
Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Tempera...
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Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Temperature ranged 99.5-101.3, l check my temp daily. Sweating, chills, headache, body aches and fatigue. The symptoms began to decline approximately 24H after vaccine but headache, mild nausea and extreme fatigue continued. I felt so bad that I missed 2 days of work and got a COVID test to be safe, as I am a nurse, results were negative and employer was made aware of reaction.
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| 53 | 2021-01-16 | numbness, tingling |
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower...
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I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
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| 53 | 2021-01-16 | tingling, pain in extremity |
I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later,...
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I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later, my entire upper arm began aching-pain from my trapezius down to my elbow. This continued throughout the weekend and then Monday, my index and middle finger began tingling (as if asleep). This symptom has never subsided. I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist. I have tired trigger injections in my trapezius, ibuprofen, muscle relaxers, heat, exercises, a steroid burst-all without relief of symptoms. I am able to move my arm and I do have strength in the extremity. I have seen a specialist in physical medicine and rehabilitation. What I believe may have triggered this reaction is that in October I had a radial and ulnar tunnel release in the same extremity. I wonder whether the medication has affected the nerves that had been manipulated during surgery. I am wondering if anyone participating gin the trial had recent surgery was well? if so, did they note any complication after receiving the vaccine. Any help you can give would be appreciated. Thanks you for your time.
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| 53 | 2021-01-16 | pain in extremity |
Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection ...
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Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection site.
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| 53 | 2021-01-16 | dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA: dizziness, headache, muscle aches, nausea, chills, fever, tir...
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Pfizer-BioNTech COVID-19 Vaccine EUA: dizziness, headache, muscle aches, nausea, chills, fever, tiredness, feeling sick
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| 53 | 2021-01-16 | pain in extremity, feeling hot |
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the...
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Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
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| 53 | 2021-01-19 | dizziness, weakness |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-19 | pain | Body aches, headache. Treated with IBU 600mg and Tylenol 1g. Symptoms lasted 48 hours. |
| 53 | 2021-01-19 | pain | Headache, body aches, low grade fever (100.6), fatigue, injection site tenderness |
| 53 | 2021-01-19 | pain |
Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection si...
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Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection site soreness, fatigue, slight mental fog.
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| 53 | 2021-01-19 | pain, facial paralysis | ON 1/20/21 DEVELOPED EYE/MOUTH DROOPING, VOMITING, NAUEA, CHILLS AND BODY ACHES. HAS CALL OUT TO PCP |
| 53 | 2021-01-19 | tremor, dizziness, pain | Shakes, fever of 102.8, sever body aches, diarrhea, headache, dizziness Lasted 24 hours. |
| 53 | 2021-01-19 | pain |
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The...
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Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
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| 53 | 2021-01-19 | pain, weakness |
chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a sp...
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chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 53 | 2021-01-21 | pain in extremity, pain | Approximately 11 hours after receiving vaccine developed chills,fever,headache,bodyaches,arm pain |
| 53 | 2021-01-21 | pain | Body Aches, took Tylenol, recovered an hour later. |
| 53 | 2021-01-21 | pain in extremity, pain, weakness |
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill...
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First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
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| 53 | 2021-01-21 | pain |
Headache that last two days. Severe chills that started day three and have continued for nine days....
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Headache that last two days. Severe chills that started day three and have continued for nine days. Nausea, diarrhea, abdominal pain, body aches, increased joint pain, increased inflammation, and increased fatigue that started day two and has continued for nine days.
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| 53 | 2021-01-21 | tenderness, pain |
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening e...
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On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.
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| 53 | 2021-01-21 | pain |
Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body ache...
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Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body aches all over body. Injection site pain as well. On 1/21/2021 at 0500 began having chills and running a fever of 102.4. The head ache subsided around 1800. The body aches and fever were gone by 0700 on 1/22/2021. At this point (1/22/2021 1450) just exhausted, but no other aches or pains. During the time of the head ache initially took Tylenol which did nothing. Then took a low dose of Ibuprofen which took an edge off.
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| 53 | 2021-01-21 | tremor, pain |
Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, ...
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Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, nausea, vomiting and diarrhea, continuous headache for 4 days. Then started with productive cough and dyspnea on exertion. Took Tylenol initially and then Proair inhaler starting 1/15
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| 53 | 2021-01-21 | swollen extremities | edematous changes in L axillary region with inflammed lymph nodes |
| 53 | 2021-01-21 | pain |
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad...
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shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
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| 53 | 2021-01-24 | tingling, dizziness, numbness |
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a...
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20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
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| 53 | 2021-01-24 | pain | T(max) 100.7 body aches chills headache and fatigue |
| 53 | 2021-01-25 | pain in extremity |
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; Thi...
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Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date. There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
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| 53 | 2021-01-25 | dizziness, pain |
Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness w...
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Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness worse when standing, facial flushing
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| 53 | 2021-01-25 | dizziness, pain |
Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone ache...
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Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, facial flushing. Missed work for 2 days and went to urgent care. Treated with APAP, Motrin, and meclizine
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| 53 | 2021-01-26 | pain in extremity |
Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without fe...
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Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without feeling extreme pain.
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| 53 | 2021-01-26 | dizziness |
On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, p...
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On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, pt developed swelling of eyelids, lightheadedness and nasal congestion. Pt reported similar symptoms related to seasonal allergies which she also experiences at this time of year. Pt self-medicated with fexofenadine (Allegra). Pt notified primary care provider. Pt denied any shortness of breath, difficulty swallowing or rash. Pt was advised to take diphenhydramine 50 mg. In no improvement in swelling, pt was advised to go to urgent care.
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| 53 | 2021-01-26 | dizziness, numbness, pain in extremity |
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ...
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dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
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| 53 | 2021-01-26 | numbness, tingling |
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn...
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elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-26 | pain | fatigue, body aches, HA |
| 53 | 2021-01-28 | migraine |
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed bl...
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Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
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| 53 | 2021-01-28 | migraine |
Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, ...
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Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, had a migraine - felt like the one I had the same day of the vaccine, but way more intense. I now wake up with headaches almost every morning.
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| 53 | 2021-01-28 | pain | FEVER, "THICK TONGUE", LOWER BODY ACHES |
| 53 | 2021-01-28 | pain |
Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient)....
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Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), intramuscular in right arm on 13Jan2021 at 07:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included diabetes and high cholesterol. The patient's concomitant medication included unspecified vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, unknown expiration) via intramuscular in left arm on 23Dec2020 at 07:15 AM in a hospital. The patient also had known allergies to codeine. The patient experienced fever and body aches on 13Jan2021 at 13:00. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The patient had not yet recovered from the events.
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| 53 | 2021-01-28 | pain in extremity |
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle ...
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Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
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| 53 | 2021-01-28 | pain |
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is ...
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lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-01-28 | pain in extremity |
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai...
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mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
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| 53 | 2021-01-28 | pain in extremity |
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh...
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she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
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| 53 | 2021-02-01 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old fe...
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Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247), via an unspecified route of administration at Left arm on 15Jan2021 11:00 AM at SINGLE DOSE for covid-19 vaccination. The patient was not pregnant. Concomitant medications in two weeks included lithium, levothyroxine sodium (LEVOTHROID), omeprazole. Historical Vaccine included first dose of bnt162b2 (lot number EL 1284) on 29Dec2020 11:00 AM at Left arm for covid-19 vaccination. The patient previously took ziprasidone hydrochloride (GEODON) and experienced drug allergies. It was reported no other medical history. On 17Jan2021 the patient woke up with left side of her face dropping. She went to the ER. She was diagnoses with Bell's Palsy. The event onset date was 17Jan2021 04:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment drugs predizone and Acyclovir received for the event. The outcome of the event was not recovered. No covid prior vaccination, no covid tested post vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-02-01 | pain in extremity, feeling hot, pain |
after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like ...
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after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like I had a fever but did not, extreme fatique
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| 53 | 2021-02-03 | pain in extremity |
Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT ...
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Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT have not Frozen shoulder Shot was close to Shoulder capulituits . I have received yesterday 2/3/2021 a cortisone shot to the shoulder and will receive PT
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| 53 | 2021-02-04 | feeling cold, dizziness, weakness |
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena...
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She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 53 | 2021-02-08 | difficulty speaking |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-14 | numbness, tingling |
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl...
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reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-17 | pain |
either tore a muscle in my lower back or herniated a disc; either tore a muscle in my lower back or ...
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either tore a muscle in my lower back or herniated a disc; either tore a muscle in my lower back or herniated a disc; achey muscles, particularly in my back; muscles were really tight; Acute pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247), via an unspecified route of administration on 03Feb2021 12:00 (at the age of 53 years) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 13Jan2021 at 09:00 AM (at the age of 53 years) at single dose in left arm. Medical history included thyroid cancer in past, euthyroid on medication. The patient has no known allergies. Concomitant medication included Levoxythyroid 137 mcg. The patient reported the following: 'The morning after 2nd dose on 04Feb2021 at 07:00 AM, I had achey muscles, particularly in my back. My muscles were really tight. I bent down to pick something up and either tore a muscle in my lower back or herniated a disc because my muscles were so tight. Acute pain now. Cannot get out of bed'. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was receiving pain meds for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events had not resolved.
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| 53 | 2021-02-21 | pain |
About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hour...
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About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hours after the shot I felt a lump under my left armpit and there was visible swelling about the length of my fist. The lump was sore and pain could be felt with touch and with squeezing my arms across my breasts. 4 days after the shot, the lump under my arm isn't very painful but there is still some swelling.
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| 53 | 2021-02-21 | dizziness |
Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient eval...
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Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient evaluated by EMS staff. BP 167/95, P 116, O2 100%. Upon further questioning, patient reports h/o POTS syndrome, autonomic dysfunction, dual chamber pacemaker and low BPs on occasion. Re-evaluated by EMS done 15 minutes later, BP 170/95, P 100, O2 100% patient refused to go to ER. Patient monitored in clinic for an additional 30 minutes. Stated symptoms had resolved.
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| 53 | 2021-02-21 | pain |
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl...
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Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 53 | 2021-02-22 | pain |
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spot...
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1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
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| 53 | 2021-02-22 | pain in extremity |
Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent ...
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Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .
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| 53 | 2021-02-22 | dizziness |
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w...
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Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
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| 53 | 2021-02-23 | weakness | having flue symptoms, no energy began on 2/14/2021 consistant |
| 53 | 2021-02-24 | pain in extremity |
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch...
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Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
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| 53 | 2021-02-25 | pain |
Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a c...
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Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a contactable health care professional, the patient. A 53-years-old female non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK 9231), via an unspecified route of administration in the right arm on 25Jan2021 at 14:30 (at the age of 53-years-old) as a single dose, for COVID-19 vaccination. Facility where the most COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included breast cancer on an unspecified date (Breast cancer survivor) and Covid-19 on an unspecified date (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included escitalopram oxalate (LEXAPRO), tamoxifen (TAMOXIFEN). The patient had no known allergies. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, The patient experienced fever of 101, body aches, like the flu, headache. The events were considered non serious. The patient underwent lab tests and procedures which included body temperature:101 fahrenheit (fever 101) on 26Jan2021. No treatment was given for the events. The clinical outcome of the events Fever of 101, body aches like the flu, headache was recovering.
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| 53 | 2021-02-25 | weakness |
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; head...
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Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 53 | 2021-02-26 | facial paralysis, numbness |
Numbing on left side of the face, unable to close left eye all the way no control on left side of th...
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Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw
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| 53 | 2021-02-28 | dizziness |
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin...
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First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
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| 53 | 2021-02-28 | numbness |
Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness ...
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Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-02-28 | pain in extremity, dizziness |
Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer ...
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Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
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| 53 | 2021-02-28 | pain |
Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers in...
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Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic. Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020. The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D. The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-03-15 | pain |
Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous...
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Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231), via an unspecified route of administration (left deltoid) on 09Jan2021 at single dose, for COVID-19 immunization. Medical history included celiacs, hypertension (HTN), thyroid disease, gastrooesophageal reflux disease (GERD), migraines, allergies: celiacs (gluten), and allergies: culturelle. Concomitant medications included levothyroxine and prednisone which was stopped 4 days prior. The patient previously took dilaudid and experienced allergies and received first dose of bnt162b2 for COVID-19 immunization on 18Dec2020, 13:15, left arm (lot ELO140). On 11Jan2021, the patient experienced severe night sweats, body aches and low grade temps continuing growth off and in since second vaccine. Patient reported to have missed work. This has been going on for 3.5 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. Outcome of events was not recovered.
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| 53 | 2021-03-16 | one side paralysis |
12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collaps...
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12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak.
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| 53 | 2021-03-17 | dizziness, pain |
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil...
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Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
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| 53 | 2021-03-17 | pain in extremity |
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM...
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neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-03-21 | dizziness | c/o dizziness, chest pressure and palpitations after vaccine administration. |
| 53 | 2021-03-22 | tingling |
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT...
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FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
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| 54 | 2020-12-31 | dizziness |
Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest...
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Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest BP 85/60, with symptoms: lightheaded at rest.
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| 54 | 2021-01-01 | pain in extremity, pain | Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea |
| 54 | 2021-01-01 | weakness, dizziness |
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head...
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Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
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| 54 | 2021-01-02 | tremor, dizziness |
5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31-...
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5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31- 2020, no adverse reaction. Friday, 1-1-2021 , entire body, including internal organs were trembling. Saturday, 12-31-2020, extremley dizzy, unable to stand, function. Nauseated, extremely dehydrated, extreme exhaustion. This lasted 24 hours. Sunday, 1-3-2020, still exhausted, but not to extreme. All other symptoms have subsided.
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| 54 | 2021-01-02 | tingling |
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, a...
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Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
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| 54 | 2021-01-03 | weakness |
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo...
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12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
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| 54 | 2021-01-03 | pain | Chills, low grade fever, severe body aches, head aches, (for 2 days) injection site hematoma |
| 54 | 2021-01-03 | tenderness, pain |
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ...
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I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
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| 54 | 2021-01-04 | dizziness |
Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (p...
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Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EK9231, expiration date unknown), via an unspecified route of administration on the left arm on 28Dec2020 at 11:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension (HTN), obesity, hypothyroid, allergies to penicillin (PCN), and was diagnosed (Dx) with an unknown virus in Feb2020. Concomitant medications included chlorthalidone (CHLORTHALIDONE), levothyroxine sodium (SYNTHROID), olmesartan medoxomil (BENICAR), atenolol, and minoxidil (PANT). The patient previously took levofloxacin (LEVAQUIN), gatifloxacin (TEQUIN), and morphine and experienced allergies from all these medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced left arm pain - mild and mild lightheadedness. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The outcome of both the events was unknown.
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| 54 | 2021-01-04 | pain, lethargy |
Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sp...
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Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.
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| 54 | 2021-01-04 | dizziness |
Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with a...
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Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with an extreme headache 9/10 and nausea. Took 325 Tylenol and brought the pain down to a 7/10. Slept for a couple of hours and woke up with a headache at a 7/10 - took 650 mg Tyleno, drank some Focus Aid and ate some veggie straws. After about 1/2 hour the headache was down to a 4/10,
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| 54 | 2021-01-04 | dizziness |
Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea ...
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Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea and a tremendous headache - 8 out of 10. Took 325 mg Tylenol and helped a little - 7 out of 10. Slept a couple of hours and the headache was still 7 out of 10. Took 650 mg Tylenol, ate some veggie straws, and drank some Focus Aid. After about 1/2 hour the headache was a 4/10. 2 hours later and headache remains, currently 5/10.
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| 54 | 2021-01-04 | vertigo | Vertigo, Positional Vertigo, Nausea/Vomiting |
| 54 | 2021-01-04 | pain in extremity |
When I first received shot my left arm start hurting. I was in contact with someone that had COVID-1...
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When I first received shot my left arm start hurting. I was in contact with someone that had COVID-19 , which I was tested positive with COVID-19.
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| 54 | 2021-01-04 | weakness, dizziness, pain in extremity |
chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fa...
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chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fatigue tiredness
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| 54 | 2021-01-04 | lethargy, pain |
chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatig...
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chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatigue; tired and lethargic; severe headache; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left deltoid for COVID-19 immunization in hospital. Medical history included allergies; COVID-19 and received her positive result on 22Oct2020, the reporter didn't know if that was pertinent, she was out of work for 15 days. Concomitant medication included lisinopril, clarithromycin (CLARITIN) for allergies, mometasone furoate (FLONASE) for allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her flu vaccine was in Oct2020. The patient received the vaccine on 28Dec2020 and was having side effects. No shortness of breath, but she did have some side effects. She felt fine most of the day. In the afternoon around 2PM (28Dec2020 14:00), she developed a severe headache and took 600mg ibuprofen and it didn't touch it. She took another 600mg of ibuprofen in the evening. She felt tired and lethargic on 28Dec2020 20:00 so she went to bed. This morning (29Dec2020) she had body aches and feels very fatigue. She still has a headache. She has chills and fever on 29Dec2020 08:00. Her temperature was 99.2 degrees Fahrenheit about 2 hours before (29Dec2020). The severe Headache was compared to last night it was better, but she still had slight headache. About tired and lethargic, driving to work she wanted to go to sleep. she was at work at her desk and she was not as tired as before. The lot number was on the card she was given. She was not sure if it was ELO140 or EL0140. No emergency room or physician office was required for any adverse event. The outcome of headache, tired and lethargic was recovering, of chills and fever was not recovered, of body aches was unknown. For events severe headache, tired and lethargic, chills and fever, the seriousness was reported as non-serious, the relatedness was related with COVID vaccine.
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| 54 | 2021-01-04 | pain | fever ,chill and achiness |
| 54 | 2021-01-04 | tremor |
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh...
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she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
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| 54 | 2021-01-05 | tremor, feeling hot |
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he...
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About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
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| 54 | 2021-01-05 | pain in extremity | After vaccine patient reported ankle, leg and hip pain. Taking Motrin |
| 54 | 2021-01-05 | tingling |
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ...
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Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
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| 54 | 2021-01-05 | pain | I had off and on body aches and a pretty severe headache for three days but no fever but nausea. |
| 54 | 2021-01-05 | tingling, pain in extremity |
I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon w...
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I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon when my arm became sore, which I expected to happen so I took Tylenol. By mid afternoon, my 4th and 5th finger on my left had began to tingle and I was having difficult typing with that hand on my keyboard. By late afternoon, the left side of my face began to tingle like paresthesia. I took more Tylenol at dinner but the sensation in my face lasted until I went to bed around 10:00. I woke up in the night and my face felt fine but my 2 fingers were still tingling and I felt like I had no control over them. When I woke up this morning, I took to more Tylenol and the symptoms have subsided. Also, when the nurse swabbed my arm with alcohol, I asked?Isn?t that a little high for the injection, and he said no?it?s right in the deltoid. It felt like the injection site was close to the bones in my shoulder but that may have had nothing to do with these symptoms.
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| 54 | 2021-01-05 | feeling hot | LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED |
| 54 | 2021-01-05 | vertigo, dizziness |
One week after the vaccine I was find until....I got out of my car after driving and started stagger...
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One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.
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| 54 | 2021-01-05 | pain in extremity, pain |
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA...
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PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
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| 54 | 2021-01-05 | pain | Temp 101.9, body aches, headache for 36 hours |
| 54 | 2021-01-05 | dizziness |
c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vit...
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c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vitals stable, Given Juice PO. 145/89, 74, 20, 100% O2sat. D/C'd after 30 minutes in stable condition 117/67, 65, 20, 100% O2 sat..
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| 54 | 2021-01-05 | pain, pain in extremity |
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi...
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patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
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| 54 | 2021-01-05 | pain in extremity, weakness |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
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| 54 | 2021-01-06 | tremor, pain in extremity | Fever, chills, headache, dry cough, left calf pain, tremor in left thumb |
| 54 | 2021-01-06 | pain in extremity, pain |
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar...
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Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
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| 54 | 2021-01-06 | pain | Low Grade fever temp 100.0, Body aches and joint aches, fatigue, |
| 54 | 2021-01-06 | dizziness | NauseaVomiting dizziness |
| 54 | 2021-01-06 | pain | Patient reported feeling, tired achy fatigued and a fever of 100 degrees |
| 54 | 2021-01-06 | dizziness |
Pt stated she felt dizzy and lightheaded. She laid down and VS were taken. BP 120/85, HR 67. Pt reco...
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Pt stated she felt dizzy and lightheaded. She laid down and VS were taken. BP 120/85, HR 67. Pt recovered and left.
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| 54 | 2021-01-06 | numbness, dizziness, feeling cold, tremor |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-06 | numbness |
shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles ...
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shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles in the L shoulder, numbness into both hands...of the left arm. And neck pain... cervical radiculopathy in the L arm... pain and pins/needles into L thumb. It reached its peak with 4 nights of disturbed sleep starting on the date mentioned. I didn?t keep track of the symptoms other than that because I didn?t initially associate the symptoms to the vaccine until early this week. Symptoms have since improved and are (almost) resolved; I was advised to have the the 2nd vaccine today as scheduled - which was recommended lower on the deltoid and on the opposite shoulder.
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| 54 | 2021-01-07 | dizziness |
About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. ...
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About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged
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| 54 | 2021-01-07 | pain |
Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous repo...
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Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization. Medical history included Hypothyroid. She was not pregnant. There were no known allergies. Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified "B". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.
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| 54 | 2021-01-07 | dizziness | Fatigue ,chills,headache, nausea,lightheaded |
| 54 | 2021-01-07 | pain | Fatigue, headache, nausea, and body aches |
| 54 | 2021-01-07 | pain in extremity |
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ p...
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Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.
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| 54 | 2021-01-07 | pain | Patient developed fatigue, headache, and body aches after receiving vaccine. |
| 54 | 2021-01-07 | pain |
Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling;...
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Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none. The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown Information on batch number has been requested.
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| 54 | 2021-01-07 | pain in extremity, pain |
Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approxi...
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Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approximately 8:00 PM. EE reports arm soreness and pain at injection site. EE reports she woke up around 04:00 with flu like symptoms, body aches (reporting so bad she is barely able to get out of bed), fever (Tmax 101.4). + runny nose, congestion and headache. EE reports + exposure to pt with only wearing surgical mask approx. 3 weeks, and was contacted by EH and was considered low-risk and not scheduled for testing. Last day of work and shift - ? yesterday left work at approx. 8:00 PM Home remedies? - Tylenol at 0700, 600 mg ibuprofen at 11:30 Any improvement? - none Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
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| 54 | 2021-01-07 | tremor |
Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf p...
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Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf pain tremors on Lt thumb - until today still with mild tremors episodes of dry cough
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| 54 | 2021-01-07 | feeling hot | Warm neck and face. Burning sensation in eyes. |
| 54 | 2021-01-07 | pain | body aches, vomitting for 12 hrs, nausea |
| 54 | 2021-01-07 | feeling cold, pain | body chills aches and headace |
| 54 | 2021-01-07 | pain in extremity, weakness, dizziness |
chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; diz...
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chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
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| 54 | 2021-01-07 | weakness, dizziness, pain |
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c...
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dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
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| 54 | 2021-01-07 | pain | fever, body aches, Heache, does not feel well, nausea |
| 54 | 2021-01-07 | tingling |
right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. ...
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right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.
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| 54 | 2021-01-07 | pain in extremity |
some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to slee...
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some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to sleep that night; This is a spontaneous report from a non-contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on 03Jan2021 (Sunday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported some arm pain (unspecified) following the injection on 03Jan2021 and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day on 04Jan2020. The outcome of event "shoulder and neck stiffness after going to sleep that night" was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 54 | 2021-01-07 | pain |
throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contract...
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throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination. Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age. Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.
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| 54 | 2021-01-08 | dizziness |
"Lightheaded", "woozy", "stressed that may play a role" @ 1524 BP 168/100 HR 68 SPO2 97% RA, @1527 B...
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"Lightheaded", "woozy", "stressed that may play a role" @ 1524 BP 168/100 HR 68 SPO2 97% RA, @1527 BP 161/87, @1532 BP 158/84, @1538 BP 151/97 Narrative: Report provided to this RN by staff, monitor post Covid vaccination: @1524 (Post 15 min monitoring after receiving vaccination) Employee reported to staff, monitor, a mild feeling of being lightheaded or "woozy" and stated " have been a bit stressed regarding news and uncertain if that is playing a role, vitals were taken. Employee agreed to stay for another 15 mins, @1538 last BP taken and Employee stated she felt better. Symptoms resolved and employee was able to go.
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| 54 | 2021-01-08 | pain, migraine |
12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning ...
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12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning fever 101.9, severe chills, severe aches of lower back, hips, joints, loss of appetite these symptoms continued thru 01/02/21 01/03/21 fevere abated, still body aches but much less severe, fatigue 01/04/21 fatigue only slowly resolving
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| 54 | 2021-01-08 | pain | Chills, fever, body aches |
| 54 | 2021-01-08 | numbness, tingling |
Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Deni...
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Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Denies any rash, mouth/throat swelling, difficulty breathing, itching, wheezing, or racing heart. Check vitals: O2 98% HR 72 BP 118/80 Monitored until 11:20. Rechecked periodically and her symptoms resolved. Advised that if symptoms return then go to ER. Discharged home.
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| 54 | 2021-01-09 | pain |
15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and v...
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15 hours of feeling febrile with no fever and severe body aches - next day woke with a painful and very swollen arm pit in the arm where i was vaccinated, today is day 2 of swollen painful arm pit.
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| 54 | 2021-01-09 | pain |
Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned na...
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Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned nauseous. Day 7: symptoms worsened . I had a fever throughout the night but fever broke my morning Day 8 post vaccine, feeling much better, no fever. I recognize these symptoms aren?t life threatening and I could have been exposed to covid after the vaccine, I don?t know. I?m just trying to help get the data out there for the pharmaceutical companies and the public to have
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| 54 | 2021-01-09 | dizziness, pain |
I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperatur...
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I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperature, I went back to bed after taking Advil until I woke up at 2pm, then took Tylenol. By 4 pm I felt much better. My injection site was much more sore than the first dose.
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| 54 | 2021-01-09 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 d...
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Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 days. Moderate headache beginning on day after vaccine, lasting for one day.
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| 54 | 2021-01-09 | pain | Pfizer-BioNTech COVID-19 Vaccine. Chills, headache, body aches, nausea, fatigue |
| 54 | 2021-01-10 | pain |
"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40...
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"1/10/21 I go the 2nd shot. My blood pressure dropped and they had to lay me down. It went to 90/40, I broke out in a rash on my neck, I am achey all over today 1/11/21"
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| 54 | 2021-01-10 | feeling hot, numbness, tingling, dizziness |
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and...
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30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
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| 54 | 2021-01-10 | pain |
Extreme Exhaustion-day of shot (01/06/2021 - 01/09/2021, Body aches - day after shot (01/07/2021),...
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Extreme Exhaustion-day of shot (01/06/2021 - 01/09/2021, Body aches - day after shot (01/07/2021), fever - day after shot (01/07/2021 - 01/08/2021, Chills - day after shot (01/07/2021), Headache - day after shot (01/07/2021-01/09/2021)
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| 54 | 2021-01-10 | pain in extremity | Fever and headache next day; sore arm next day; headache and sore arm lasted through 1/11/21 |
| 54 | 2021-01-10 | pain in extremity, numbness, pain, restlessness |
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ...
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Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
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| 54 | 2021-01-10 | dizziness |
Patient complained of dizziness and feeling of something in her throat. She felt the need to clear h...
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Patient complained of dizziness and feeling of something in her throat. She felt the need to clear her throat.
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| 54 | 2021-01-10 | pain, pain in extremity |
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri...
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Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
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| 54 | 2021-01-10 | dizziness | Shortness of breath, Fatigue, muscle aches, chest pain, dizzy and light headed, headache |
| 54 | 2021-01-11 | pain in extremity |
Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soren...
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Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soreness, nausea. I also checked my b/p. It was more elevated than usual. (130/90?s). These symptoms subsided 24-48 hours after the vaccine.
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| 54 | 2021-01-11 | bell's palsy | Bell's Palsy |
| 54 | 2021-01-11 | pain | Fever, body aches, extreme chills, nausea, fatigue. >16 hrs |
| 54 | 2021-01-11 | pain, pain in extremity |
HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms comple...
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HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms completed resolved.
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| 54 | 2021-01-11 | pain |
I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every...
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I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. On Jan2021, the patient reported that: "I am running my temperature 100.1, chills in my body and my body is still painful. I don't have shortness of breath, but I am very painful. I took 2 TYLENOL. I woke with chills, I have my body achy, my back hurts. I am in pain, every joint hurt in me. I took my temperature and I realized it was 100.1". The patient outcome of fever and chills was unknown, the outcome of the other events was not recovered. Information on Lot/Batch has been requested.
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| 54 | 2021-01-11 | pain, migraine |
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that ...
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I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home. The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
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| 54 | 2021-01-11 | pain in extremity |
I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I ...
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I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I also had chills on 12-25-2020 with muscle aches. The muscle aches got worse on 12-26-2020 and that's when I visited an urgent care center. At the ER they did a nasal swab test, covid test.
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| 54 | 2021-01-11 | pain |
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right...
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Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
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| 54 | 2021-01-11 | dizziness |
Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizzi...
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Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizziness, joint pain
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| 54 | 2021-01-11 | pain |
Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment:...
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Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment: Tylenol 325mg (650mg Q4hrs) followed by Naproxen 250mg (Q12hrs), lots of fluids and rest Time Course: 2 days
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| 54 | 2021-01-11 | dizziness |
Within 12 hrs of first dose of Pfizer Covid vaccine, patient experienced tiredness. Within 36hrs pat...
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Within 12 hrs of first dose of Pfizer Covid vaccine, patient experienced tiredness. Within 36hrs patient experienced nausea, severe headache, and dizziness. Patient reports after these symptoms she had to stay in bed for the next day but by day 4 she was significantly improved and just tiredness occurred over the weekend. 6 days total.
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| 54 | 2021-01-11 | weakness |
crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; havi...
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crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
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| 54 | 2021-01-11 | pain |
fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactab...
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fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactable Nurse reporting for herself. A 54-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose in left deltoid for COVID-19 immunisation at the age of 54-year-old. Lot number was EL1284. Medical history included Asthma since 1991 and ongoing, high blood pressure since 2020 (6 months before the report) and ongoing. Concomitant medications were unknown. On 07Jan2021, the patient experienced fever of 103.7 at 1:30PM, chills at 9:00AM, body aches at 11:00AM, Joint pain at 09:00AM, cough at 1:00PM; the events were considered medically significant. The patient was not treated for the events. On 13Nov2020, test showed she had COVID-19. On 07Jan2021, body temperature was 103.7 Fahrenheit. The patient did not recover from the events. The nurse considered the events were related to suspect vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 54 | 2021-01-11 | pain in extremity |
rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable...
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rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
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| 54 | 2021-01-11 | vertigo, dizziness |
severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report fr...
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severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 54 | 2021-01-11 | pain | woke up next morning body aches headache sneezing and running nose |
| 54 | 2021-01-12 | pain |
14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of ...
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14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of nausea hit and passed out falling on floor. Had slight stomach upset and significant chills. Took Tylenol and was recovered by 8 a.m.
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| 54 | 2021-01-12 | pain in extremity, feeling cold |
Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around...
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Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around 10pm). Still felt a slight headache the next morning (5:30am) and took two more tablets. Felt fine after that. I felt kind of cold during the evening, but by the time I went to bed around 10pm, that was when the chills had hit full force. I could not get warm enough. I continued to increase the temperature of my electric blanket and was not comfortable until I was at a 6 out of 10. When I woke up the next morning the chills were gone. Also experienced soreness in the left arm.
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| 54 | 2021-01-12 | dizziness, weakness | NAUSEA AND VOMITING, WEAKNESS AND DIZZINESS, FATIGUE, SORE MUSCLES |
| 54 | 2021-01-12 | pain, pain in extremity |
Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues...
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Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues and head pressure ( took Tylenol ) 8pm body aches, stiffness back of my neck, soreness on L arm worsen. Next morning 1/13/21 L side arm, back and neck stiff, soreness and backaches, and also chills, hands are clammy and headache.
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| 54 | 2021-01-12 | pain |
aches/pains shooting down my right leg; severe lower back pain; This is a spontaneous report from a ...
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aches/pains shooting down my right leg; severe lower back pain; This is a spontaneous report from a contactable nurse. This 54- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK5730), via an Intramuscular route of administration, on 06Jan2021 at 09:00 AM (at the age of 54-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. The patient reported allergies to food. The patient does not have any medical history. Concomitant medication included omeprazole ((MANUFACTURER UNKNOWN) 20 mg QD, diclofenac (MANUFACTURER UNKNOWN) 75 mg EC tablet QD. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 3:00AM, 18 hours after 1st dose, she experienced severe lower back pain with aches/pains shooting down my right leg. Nine hours, after the injection I took 1 gm of Tylenol. At 3 am, I took another 1 gm of Tylenol with some relief. At 8 am took 400 mg of Motrin with some relief-aches/pain still there. No paralysis or weakness. The patient received Tylenol and Motrin as treatment for the events. The clinical outcome of the events aches/pains shooting down my right leg and severe lower back pain was not recovered. Patient was not tested for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-01-13 | tenderness, pain in extremity |
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this...
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1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued. mild fatigue 6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening 7:30 pm 2nd dose 1000mg acetaminophen 1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort. Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms. Fatigue improved. Headache mostly resolved. Took 1000 mg acetaminophen.
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| 54 | 2021-01-13 | pain |
48 hours of fever up to 102 degrees. Severe headache, fatigue and bodyaches. Nausea and severe arm...
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48 hours of fever up to 102 degrees. Severe headache, fatigue and bodyaches. Nausea and severe arm pain radiating to neck. Took tylenol and tramadol for 36 hours and then symptoms began to subside. By the third day post vaccine, all symptoms except for fatigue resolved.
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| 54 | 2021-01-13 | balance disorder, dizziness |
Approximately 20 hours after the vaccine I woke up very confused. I was dizzy. I had a very poor s...
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Approximately 20 hours after the vaccine I woke up very confused. I was dizzy. I had a very poor sense of balance and could only walk by holding onto walls. This resolved after approximately 10 hours
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| 54 | 2021-01-13 | pain in extremity | Arm soreness |
| 54 | 2021-01-13 | feeling cold |
Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing,...
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Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 54 | 2021-01-13 | pain | Chills , body aches, fatigue, swollen lymph nodes in right axilla, throat, and under right clavicle |
| 54 | 2021-01-13 | pain | Chills 2 hours Headache 36hours Body aches 36 hours |
| 54 | 2021-01-13 | pain in extremity, pain |
Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm ...
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Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm pain. Took tylenol and tramadol for pain and fever.
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| 54 | 2021-01-13 | pain in extremity |
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within...
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I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?) Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
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| 54 | 2021-01-13 | pain in extremity | Rash and redness around injection site Arm soreness Chills Fever |
| 54 | 2021-01-13 | feeling cold, pain, tremor |
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s...
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She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-13 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-ye...
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Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), via an unspecified route of administration on 22Dec2020 at 13:30 at single dose at left arm for COVID-19 immunization. Medical history included hypertension and hypothyroidism. The patient had no known allergies and no allergies to medications, food or other products and patient was not pregnant. The patient's concomitant medications were not reported. On 22Dec2020 at 13:30, the patient experienced sore arm. There was no therapy received for the event. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had other medications that was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
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| 54 | 2021-01-13 | restlessness, dizziness |
Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. W...
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Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. Went to the bathroom and had diarrhea and then began to vomit. My temp spikes to 102.6. Had a restless night but by the next evening I was fine, no issues or fever.
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| 54 | 2021-01-13 | pain, dizziness | TEMP LOSS SENSE OF TASTE BODY ACHES, MUSCLE CRAMPS, FATIGUE SEVERE HEADACHE DIZZINESS LIGHT HEADED |
| 54 | 2021-01-13 | dizziness | c/o dizziness, SOB, hives, "flushed" |
| 54 | 2021-01-13 | pain in extremity, pain |
sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling we...
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sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling well
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| 54 | 2021-01-14 | pain in extremity, tingling, pain |
12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet...
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12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet to legs. I called office and put on prednisone for 3 days. Then another 7 days prescribed; 12/23rd 1st vaccine; The same day, I was having the tingling and pain came back after the shot. But I still had had from flu shot, it just came on stronger. It wasn't as bas as after the flu shot. Took another 10 days of prednisone. 1/13/2021 2nd vaccine; sore arm, little tired. But could be as I had to wake up early.
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| 54 | 2021-01-14 | numbness, tremor |
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV...
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1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
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| 54 | 2021-01-14 | facial paralysis |
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,...
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1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
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| 54 | 2021-01-14 | dizziness, weakness |
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ...
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Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
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| 54 | 2021-01-14 | pain, pain in extremity | Fever 100.4, headache, nausea, body aches, right arm soreness |
| 54 | 2021-01-14 | pain |
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea....
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Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
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| 54 | 2021-01-14 | pain | Fever 101f Diarrhea Aches and pains Headache |
| 54 | 2021-01-14 | one side paralysis |
Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakn...
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Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakness in my right hand had become progressively worse since dec 30 or 31 st . Had the second shot on Jan 11 . In last 2 data I am having trouble holding a mug or iPhone in right hand . It feels very numb From Jan 12 to today my right hand is having trouble gripping pen , hair brush , difficult to open doors .
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| 54 | 2021-01-14 | feeling cold, numbness, tremor |
I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate...
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I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate 1/2 banana and drank some water. I started to drive home. It felt like a huge cold railroad spike was being driven up the top of my shoulder to my neck, it was a cold sensation anteriorly and posteriorly on my neck. Then my face (left side) started to go numb, it started just about the top of my left ear and went all the way to my lips. It stopped midline. It felt like a dental block. I could still swallow and breathe. I started shaking, felt nausea, my upper esophageal sphincter started to spasm. I kept checking my tongue and airway to see if I should pull over and call 911. I drove to the ER. My left side of face was numb, I was trembling, tremoring. They gave me small dose of IV Bendadryl (12.5 mg) and Pepcid, I slowly started to feel better and the feeling came back to my face moving from midline lip to cheek. It still felt "funny" but much better. I was in the ER for around 2 hours. I have had more tremoring since my vaccine in my neck and hand (I do have primary essential tremors but it is tremoring much more now) and more neck pain (could be due to the increased tremors)
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| 54 | 2021-01-14 | pain in extremity |
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose...
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Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
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| 54 | 2021-01-14 | pain, pain in extremity |
Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, head...
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Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Nauseous with injection.; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), intramuscular at left arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included migraine and No known allergies. Concomitant medication included sumatriptan succinate (IMITREX), fluoxetine hydrochloride (PROZAC). The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization at right arm on an unknown date. The patient experienced nauseous with injection on 08Jan2021. Next day (09Jan2021), she had sore arm, neck, body, headache, tired chills, afebrile. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about lot and batch number was requested.
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| 54 | 2021-01-14 | pain in extremity |
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour...
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Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
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| 54 | 2021-01-14 | pain |
convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints wer...
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convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
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| 54 | 2021-01-15 | pain | Body aches Chills Fever Exhaustion |
| 54 | 2021-01-15 | dizziness | Dizziness and Palpitations within 15 minutes of vaccine administration |
| 54 | 2021-01-15 | pain | Fever Body aches Headache Nausea |
| 54 | 2021-01-16 | vertigo |
Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no r...
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Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no real nausea. Vertigo still present but now minimal. That same night I had a mild fever, but I am not concerned by this. Had some mild vertigo after the first vaccination (lot EH9899) but it only lasted 48 hrs.
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| 54 | 2021-01-17 | vertigo, weakness |
I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed...
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I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
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| 54 | 2021-01-19 | pain, pain in extremity |
2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat any...
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2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat anything). Started on 1/6 in morning and gone by night of 1/6.
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| 54 | 2021-01-19 | pain | HEADACHE,FEELING SICK,PAIN ON SHOULDER,PAIN ALL OVER THE BODY AND TWO EPISODE OF VOMITING. |
| 54 | 2021-01-19 | pain, restlessness | LOW GRADE FEVER, BODY ACHES, HEADACHE, RESTLESSNESS, TIREDNESS. TOOK TYLENOL EVERY 6 HRS AND REST. |
| 54 | 2021-01-19 | pain, inability to speak, vertigo, dizziness, lethargy |
On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and...
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On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and shoulders. Along with aching all over. Over the course of the day, I started to feel bad. Then on Monday January 18, 2021, in addition, to the joint pain, I started feeling disoriented, dizzy like spells of vertigo. I went to my PCP who did lab work and all was normal. He said it muse be delayed reaction to the vaccine. Later in the day, I was having difficulty putting words together and more dizzy and very lethargic. I laid down and slept until the next morning. (Tuesday 1/19/21) On Tuesday 1/19/21, they symptoms were improved but still had some dizziness. On Wednesday 1/20/21, the symptoms have improved except for an occasional dizzy spell.
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| 54 | 2021-01-19 | dizziness |
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ...
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Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
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| 54 | 2021-01-19 | pain | body ache, headache, cough. called in sick to work. |
| 54 | 2021-01-19 | pain, dizziness |
fever; aches; feeling faint; fatigue; This is a spontaneous report from a contactable Nurse (Patient...
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fever; aches; feeling faint; fatigue; This is a spontaneous report from a contactable Nurse (Patient). This 54-year-old female patient (No pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Left arm on 08Jan2021 15:00 at single dose (Lot EK9231) for covid-19 immunisation. No other vaccine in four weeks. Medical history included allergies: Sulfa, Augmentin. Concomitant medications included ciclosporin (RESTASIS, eye drops), mometasone furoate (FLONASE), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN), ipratropium and xylometazoline hydrochloride (NASAL SPRAY II). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on Left arm on 17Dec2020 04:30 PM (Lot: VK5730) for covid-19 immunisation. The patient woke up 09Jan2021 at 7:00 am with fever (did not use thermometer) Aches, feeling faint, fatigue, took Advil and slept until 2pm, then took Tylenol and Felt better by 4pm. Outcome of the events was recovered.
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| 54 | 2021-01-21 | pain in extremity, pain |
Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever u...
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Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever up to 100.9 even on Tylenol. Symptoms were more than moderate. Had to alternate Tylenol and Advil every 3 hours for fever. Arm soreness started just hours after shot and hurt even when arm was stationary. Other symptoms started overnight and lasted through the next night. Received shot We?d at 4:30 and took until Friday for major symptoms to subside. Still with some congestion, runny nose and tiredness as of today (Friday).
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| 54 | 2021-01-21 | pain | HEADACHE, LOW GRADE FEVER, CHILLS, ACHES, FATIGUE DEVELOPED 1/19/21 @1300, ENDED 1/21/21 @0630 |
| 54 | 2021-01-21 | pain |
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s...
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Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-21 | weakness | SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES |
| 54 | 2021-01-21 | numbness, difficulty speaking, tingling |
Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezin...
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Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezing, difficulty breathing. Transported to ER
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| 54 | 2021-01-21 | numbness |
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk...
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Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
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| 54 | 2021-01-21 | pain | temp 100.2-100.6/fever/chills, body aches, injection site L.arm very sore/heavy/painful |
| 54 | 2021-01-21 | tremor |
was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with s...
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was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with slight low blood sugar , known by slight tremor in hands and body and also resolving 30 min after eating proteins and drinking orange juice. A few hours later around 5pm began getting headache, ate dinner and did not resolve so I took 100mg of Tylenol . could not sleep and was awake until 1am woke at 930 am with low sugar again resolved after eating and drinking orange juice. Had a headache less severe only took 500 mg of Tylenol it resolved. Stayed awake all day was fatigued. no other remarkable symptoms the rest of the day. the next day was about the same only less severe and by the fourth day I only noticed being tired during the day. I think it resolved completely by the 7th or 8th day I lost track due to my step mother coming out of rehab after having had COVID in December. as I write this I am fine and it is 1/22/21
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| 54 | 2021-01-24 | pain | Body aches, chills, fatigue ,fever, SOB. sweats, joint pain. |
| 54 | 2021-01-24 | pain in extremity, pain |
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm...
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Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
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| 54 | 2021-01-24 | pain | Fever, body aches, lump on arm, nausea, headache less than 24 hours, treated with meds |
| 54 | 2021-01-24 | tingling, difficulty speaking, numbness |
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg ...
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Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
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| 54 | 2021-01-25 | pain |
1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of n...
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1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of neck to back of head, saw doctor, was given a muscle relaxant, pain worsened, went to ER was given valium and sent home 1/15 called doctor, was given hydrocodone, increased pain, went to ER due to pain, was hospitalized 1/19 discharged from hospital, off work till 2/3/2021 per PCP
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| 54 | 2021-01-25 | feeling cold, dizziness, feeling hot |
After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your abo...
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After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your about to pass out. Then tightness of chess where its hard to breath. EMS were around to give me 2 shots of Epi one at a time with the interval of about 5 to 15 minutes. the first Epi was OK but still having hard time breathing and the second one feels a lot better but cant stop shivering's. then I was transferred to emergency room and treated also with some allergy med. (Benadryl administer through IV)
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| 54 | 2021-01-25 | pain | Fever, chills, terrible body aches, unrelenting headache, nausea for 14 hours |
| 54 | 2021-01-25 | pain |
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid...
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I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
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| 54 | 2021-01-25 | dizziness |
Non-dose-related adverse reaction to medication, initial encounter Diagnosis management comments: Pa...
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Non-dose-related adverse reaction to medication, initial encounter Diagnosis management comments: Patient is a 54-year-old female with a history of hyperlipidemia presenting to the ED with complaints of dizziness and headache after receiving the second dose of the COVID-19 vaccine. Upon presentation to the ED and exam, patient reports that she is feeling a lot better at this time. She denies any chest pain, shortness of breath, hives or any feelings of her throat closing. On exam the patient's heart rate is regular lung sounds are clear. No evidence of rash noted. No angioedema noted on exam. She was given p.o. Tylenol here in the emergency department. She was monitored here in the emergency department with no further adverse reactions noted.
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| 54 | 2021-01-25 | pain | Reported tightness in throat, headache, fever,body aches, and blurry vision. |
| 54 | 2021-01-25 | pain in extremity |
axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection ...
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axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; patient received the covid vaccine on the 30Dec had a sore arm; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at single dose on the arm for COVID-19 immunization. The patient medical history included "had classic symptoms of COVID, but had a negative COVID test" on Dec2020. Concomitant medications were not reported. The patient previously had a Tetanus vaccine 23 years ago. After receiving patient spiked a fever 101 and cellulitis at the site. Reporter explained she is not 100 percent sure. She is not sure if the nurse used the DTap abbreviation and truly administered the Tetanus shot. Reporter indicated she is not sure which preparation patient got. Patient received the vaccine on 30Dec2020 and her arm was sore that day when went to bed. The next morning (31Dec2020) the site was tender. She then noticed a nickel size (as reported) red lump that had disappeared on 03Jan2021 (The next day she had tenderness and redness that went away after two days). Patient noticed the 50 cent size (as reported) lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site the morning of 31Dec2020, an exact time was not specified. On 07Jan2021 he had a 50 cent size lump on the side of her arm at injection site in arm received injection that was raised, warm, red, and tender at the injection site. On 07Jan2021 her axillary was tender and occasionally painful. On 08Jan2021 it returned to injection site at 1. That day at 6:30 PM on 08Jan2021 she had an area she had a 50 cent size area that was raised, red, and warm. She took Benadryl the next day. The morning of 09Jan2021 she woke up and had more redness tenderness in her arm, therefore, she called her doctor. Her doctor ordered an antibiotic. On 11Jan2021 they entered in the follow-up notes she had slow improvement even though the axillary area is still painful. Reporter explained it sounds like events are slowly improving, they are not completely resolved. Reporter stated it is so weird that the sore arm went away, disappeared, and then came back again. The final outcome of the events was recovering. The adverse events di not require a visit to the emergency room or physician office. The events were as assessed as non-serious by reporter. The causality of events was considered as related by reporter. Information on the Lot/Batch number has been requested.
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| 54 | 2021-01-25 | pain | mild fever, body-aches, headaches |
| 54 | 2021-01-26 | dizziness, balance disorder |
1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. ...
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1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. 1651: no symptoms BP 111/86, HR 54 1705: Hands colder than normal 1708: observed for 30 minutes; BP 127/68; HR 53; still cold hands. off balance, neck pain. 1717: continues to report feeling off and didn't wan tto leave. moved to chair for more observation and given crackers. 1726: Warming up, felt normal, felt okay to leave. Release home.
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| 54 | 2021-01-26 | feeling hot |
I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot....
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I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot. It was there for two days and went away. I had a 2.5cm hot spot on my chin and the left cheek saw red and hot.
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| 54 | 2021-01-26 | feeling hot |
I had a red hot rash on my face that lasted about a week. During the night, I woke to my face cover...
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I had a red hot rash on my face that lasted about a week. During the night, I woke to my face covered all over after being clear at bedtime.
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| 54 | 2021-01-26 | pain |
I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling...
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I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling body aches and ran a low grade fever of 100 around 5:00 P.M. on 1/26/2021. The injection site has a lump about the size of a quarter, red and warm to the touch. I took two Tylenol at 9:30 P.M. on 1/26/2021 and went to bed. I awoke at 7:30 A.M. on 1/27/2021 feeling fine, but he injection site is still swollen, red and warm to the touch.
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| 54 | 2021-01-26 | dizziness |
Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vac...
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Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vaccine. (per son accompany by patient for vaccine). Pt then became SOB and complained of chest pain. Patient appeared disoriented. EMS already station on the scene was notified by staff. Patient evaluated by EMS.( Patient's son reported patient had mild reaction after 1st vaccine but recovered quickly). Patient was taking to ER by EMS for further evaluation.
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| 54 | 2021-01-26 | dizziness, tremor, weakness |
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we...
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Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
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| 54 | 2021-01-26 | vertigo, dizziness |
Vertigo the morning after the shot. Very slight dizziness the rest of the day. Vertigo was back the ...
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Vertigo the morning after the shot. Very slight dizziness the rest of the day. Vertigo was back the next day in the morning just after waking up.
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| 54 | 2021-01-28 | pain | FEVER, SORE THROAT, BODY ACHES, HEADACHE |
| 54 | 2021-01-28 | feeling hot | Whole body hot, then general malaise, cephalgia and insomnia. |
| 54 | 2021-01-31 | weakness, tingling, numbness, dizziness |
Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalanc...
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Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up. Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness. She also had a slight fever that followed her 2nd dose of COVID-19 vaccine. She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia. She admits that she had heavy alcohol use over the weekend with binge drinking of liquor. She otherwise does drink a couple of mixed drinks a night. She has also been trying to lose a lot of weight. She says that she lost about 60 lb in the last 6 months on purpose. She is doing this so that she can have a panniculectomy and tummy tuck. She recently had a breast reduction in November. She has not been following with a dietitian or having her vitamin levels checked. Despite having pancytopenia, her levels remained pretty stable during her stay. She had a peripheral smear sent which was pending at the time of discharge. She was also checked for vitamin deficiencies. She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements. She does take a daily multivitamin. Due to her reported history of heavy alcohol use she is also given thiamine and folate. After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th. I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss. I prescribed her calcium vitamin-D along with folic acid. I recommended she continue her multivitamin. I also recommended that she abstain from alcohol use.
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| 54 | 2021-01-31 | pain in extremity, swollen extremities, pain |
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ...
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body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
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| 54 | 2021-02-01 | weakness, dizziness, pain in extremity |
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea...
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kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
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| 54 | 2021-02-02 | numbness |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-04 | numbness |
bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tight...
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bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.
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| 54 | 2021-02-07 | tingling, numbness |
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE...
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next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
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| 54 | 2021-02-09 | dizziness | SHORTNESS OF BREATH, DIZZYNESS |
| 54 | 2021-02-12 | pain in extremity |
Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion ...
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Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion to exam that has continued to progress despite broad-spectrum antibiotics, now s/p OR cut down x3 with no e/o necrotizing fasciitis. Initially most c/f infection/cellulitis, however in discussion with ID, rheum, and derm and given progression of rash in s/o broad spectrum Abx and negative tissue cultures, now most suspicious for cellulitic variant of Sweet's syndrome (SS). Pathology report w/neutrohpliic inflammation w/evidence of ischemia, w/o evidence of infection, c/w Sweets Syndrome. While this is a rare disorder, it primarily occurs in the setting of recent infection or malignancy. Currently working up potentially triggers. Infectious work up thus far negative. Hematologic malignancy most often linked with SS, given new and worsening pancytopenia, will consult heme for recommendations for additional work up. Other potential triggers include vaccinations (question about COVID vaccine recently) and often idiopathic. Maintain of treatment for SS is steroids, dermatology currently managing dosing.
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| 54 | 2021-02-21 | feeling hot, pain in extremity, pain |
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he...
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Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
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| 54 | 2021-02-21 | dizziness |
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi...
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Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
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| 54 | 2021-02-21 | dizziness |
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108...
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At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
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| 54 | 2021-02-21 | numbness |
Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Mov...
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Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
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| 54 | 2021-02-21 | pain in extremity |
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s...
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This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
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| 54 | 2021-02-22 | tingling, one side paralysis |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-22 | dizziness |
Patient became mildly short of breath with some chest tightness and light headedness approximately 2...
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Patient became mildly short of breath with some chest tightness and light headedness approximately 23 minutes after receipt of the vaccine. She notified the nursing counter who notified me. Patient was A&Ox3 upon my arrival and able to speak in full sentences. Heart rate was noted to be 105 bpm. 50mg oral Benadryl was administered and patient was monitored for 25 minutes. Heart rate improved as did patient's work of breathing, chest tightness, and her dizziness subsided completely. Her final heart rate at time of discharge was 93 bpm and patient was able to ambulate under own power to depart the site. She was escorted to her husband's vehicle and he received instructions to take her to the hospital to fill her epi-pen prescription which was placed at the time of the incident as well as reasons to use the epi-pen and report to ED if needed.
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| 54 | 2021-02-22 | pain in extremity |
ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense mala...
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ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense malaise for 24 hours followed by 2.5 days of fatigue
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| 54 | 2021-02-25 | dizziness, tingling, feeling cold |
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu...
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After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
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| 54 | 2021-02-28 | pain in extremity |
Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigu...
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Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
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| 54 | 2021-03-01 | involuntary muscle movements |
I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very...
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I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.
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| 54 | 2021-03-02 | pain in extremity, pain |
Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-...
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Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 15:15, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 26Jan2021, at 04:00 AM, the patient experienced sore arm and body aches. The events were considered non-serious. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.
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| 54 | 2021-03-02 | pain, tremor |
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells...
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Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
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| 54 | 2021-03-02 | pain |
exhausted; body aches; headache; This is a spontaneous report from a contactable consumer (patient)....
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exhausted; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (non-pregnant) received second dose of (BNT162B2, Solution for injection, Batch/lot: EL3248), via an unspecified route of administration on 03Feb2021 14:30 at single dose in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Historical vaccine of BNT162B2 for covid-19 immunisation, (administration date: 15Jan2021, time=02:30 PM, vaccine location: Left arm, dose number: 1, lot number: EL3248). Concomitant medication included desvenlafaxine succinate (PRISTIQ), levofloxacin (LEVOXAL), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc, calcium. The patient was exhausted, body aches and had headache on 04Feb2021 and it started 04:30 AM. The treatment was not received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. The outcome of the events was recovered on an unspecified date of Feb2021.
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| 54 | 2021-03-07 | pain in extremity |
Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A...
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Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.
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| 54 | 2021-03-09 | pain in extremity |
sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days l...
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sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.
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| 54 | 2021-03-13 | feeling hot, tingling, numbness |
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ...
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pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
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| 54 | 2021-03-16 | involuntary muscle movements, dizziness, vertigo |
On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being ...
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On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being thrown. My head was thrown forward and I hit the counter hard and sustained a large contusion above my left eye. The room was spinning and I was dizzy for the next few hours. I never lost consciousness but had no control of my body for the few seconds of the episode. The episode was sudden and violent and I was just sitting when it happened. I spoke with my physician who diagnosed me with having experienced a Tumarkin otolithic crisis. He has instructed me to wear a helmet and not to leave my home. He is also recommending that I have a labyrinthectomy to treat the symptoms. While I have a history of vertigo, I have not had any dizziness for more than a year. I now feel dizzy on and off most of the day.
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| 54 | 2021-03-20 | feeling hot |
I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; ...
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I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; feeling hot and clamy; nausios; i could not breathe; It was like a really bad asthma attack; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EN6208), via an unspecified route of administration i as single dose in arm left on 10Mar2021 for COVID-19 immunisation. Medical history included known allergy to penicillin. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 04:30 morning the patient experienced woke up with a headache, feeling hot and clamy, nausios. She took Iboprofin and was fine. On 12Mar2021 night she went to bed about 10 pm and woke up from a sound sleep about 12:30 am she could not breathe. It was like a really bad asthma attack which she have never had like that. It took a while to try to breath thru her nose but finally she was able to and took a nebulizer treatment with Abutero. She was very scary. She was wondering if she should take the 2nd dose. The events were considered life threatening. Therapeutic measures were taken as a result of events. Covid was not tested post vaccination. The outcome of events was not recovered.
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| 54 | 2021-03-22 | migraine |
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued na...
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Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
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| 55 | 2021-01-01 | dizziness |
Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved ...
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Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved within 15 minutes.
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| 55 | 2021-01-03 | dizziness |
5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling s...
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5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.
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| 55 | 2021-01-03 | pain in extremity | Arm soreness Swelling Overall body feeling shaky |
| 55 | 2021-01-03 | pain, pain in extremity |
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi...
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Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
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| 55 | 2021-01-03 | pain |
Received the shot 1710 on 12/21/20. Restless sleep. Awoke with body aches, took 1000mg Acetaminop...
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Received the shot 1710 on 12/21/20. Restless sleep. Awoke with body aches, took 1000mg Acetaminophen. Felt fine until 1500, started with fever/chills, temp 100.8. Went to sleep then, awoke at 1845 with oral temp at 103.4. Took 2nd dose 1000 mg Acetaminophen. Temp decreased to 102. 5 within 45 mins, dropped to 101 by 2030.
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| 55 | 2021-01-03 | dizziness |
Stated she felt "light-headed" @ 1805. Denies being "light-headed" before vaccination. States that...
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Stated she felt "light-headed" @ 1805. Denies being "light-headed" before vaccination. States that she felt the same way after she received her influenza vaccine this year. This nurse assisted Ee on bed in clinic for 15 mins. State she felt better @ 1830. Left observation @ 1830. V/S BP-122/76, P-56, O2-98.
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| 55 | 2021-01-04 | dizziness |
During her 15 minute waiting period after the injection, the patient began to experience dizziness, ...
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During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) dose number 1, intramuscularly on an unspecified date at single dose on left arm (left deltoid muscle) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had no history of previous hypersensitivity reactions to immunizations. During her 15 minutes waiting period after the injection, the patient began to experience dizziness, anxiety. She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain. Planned action included: observation, serial examination. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was unknown. Assessment by reporter: transient anxiety associated with COVID vaccine administration. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | pain in extremity |
Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-conta...
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Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an "intermittent stabbing headache" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | balance disorder, pain in extremity |
I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS ...
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I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS CAUSING ME TO LOSE MY BALANCE. IT FEELS LIKE ITS GOING TO GIVE OUT WHILE WALKING. THE PAIN TRAVELS DOWN MY WHOLE LEG. IF I STAND STILL OR SIT FOR A WHILE ITS HARD FOR ME TO PUT WEIGHT ON MY LEG. I HAVE NEVER HAD PAIN IN MY LEG LIKE THIS BEFORE. I WAS TOLD TO LET VSAFE KNOW DURING MY CHECK IN AND WILL CALL THE NURSE ON DUTY TONIGHT. IT'S BECOMING UNBEARABLE. I AM DUE FOR MY 2ND DOSE ON THE 8TH .
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| 55 | 2021-01-04 | feeling hot, dizziness |
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ...
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PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
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| 55 | 2021-01-04 | dizziness |
Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed fee...
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Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | vertigo, dizziness |
Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nause...
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Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nausea/ Acute nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 at left deltoid, at single dose for covid-19 immunization. Medical history included patent foramen ovale in patient's heart from 2013 and ongoing, and the patient used to be 5'4" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from 2013 and ongoing for patent foramen ovale. The patient got the Pfizer vaccine on 17Dec2020 and on 25Dec2020 had experienced acute nausea and dizziness that persisted during weekend. Stated that it is now full blown vertigo. Stated that her doctor and pharmacist stated that people reported symptoms but did not know if these were symptoms of the vaccine because it is not listed. The patient experienced stuff head on 28Dec2020. Stated that the nausea comes and goes. Stated that she got physical therapy treatment Epley for vertigo on 28Dec2020 and it did some good but she woke it with it again this morning on 29Dec2020. Stated that the therapy lessened her nausea as well. Stated vertigo was manageable 25-26 and then did not feel safe walking in her home on 26Dec2020. Stated that she had no symptoms after she received it up until 25Dec2020. Stated that she will get the second dose 07Jan2021. The outcome of the events was not recovered.
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| 55 | 2021-01-04 | tenderness | noted swollen lymph node left armpit area, slightly tender |
| 55 | 2021-01-05 | dizziness |
5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lig...
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5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded. Patient has a history of anaphylaxis and had Epi Pens with her. 1600 Vitals: BP: 184/72 P: 117 SaO2: 100% Epi Pen self-administered. 1605 Vitals: BP: 125/74 P:103 SaO2: 100% Nurse transferred patient to ER in wheelchair for further treatment and evaluation.
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| 55 | 2021-01-05 | pain in extremity |
Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; ...
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Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-01-05 | weakness, pain in extremity |
On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine ski...
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On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine skiing, Nordic/skate skiing or hiking uphill, I developed rapid onset, severe, debilitating, crippling 8/10 pain in my right fectus femoris thigh muscle. Duration of spasms 1-2 seconds, frequency every 10-15 minutes while exercising up to 6 hours/day. Self treatment included taking Ibuprofen 400 mg tabs po daily, OTC electrolytes po daily, application of topical diclofenac (Voltaren) gel, increase in hydration of non caffeinated/non alcoholic beverages; without any improvement.
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| 55 | 2021-01-05 | lightheadedness |
Patient was very nervous prior to vaccination, and immediately after the injection, she developed va...
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Patient was very nervous prior to vaccination, and immediately after the injection, she developed vasovagal reaction. It took her at least 30 minutes to recover, but was stable and went home with spouse.
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| 55 | 2021-01-05 | lightheadedness |
Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasova...
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Patient was very nervous prior to vaccination, and immediately after the injection, she had a vasovagal reaction. It took her at least 30 minutes to recover, but was able to go home with spouse.
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| 55 | 2021-01-05 | dizziness, feeling cold |
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure wa...
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Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of "White Coat Hypertension". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
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| 55 | 2021-01-06 | pain |
12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Tempe...
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12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Temperature was in the 101.5 range for more than 24 hours, About 30 hours with a fever.
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| 55 | 2021-01-06 | dizziness |
Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observatio...
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Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observation from 11 am to 5 pm
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| 55 | 2021-01-06 | pain in extremity, weakness |
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ...
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Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
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| 55 | 2021-01-06 | migraine, pain | Migraine sore arm nausea body aches stiff elbows |
| 55 | 2021-01-06 | pain in extremity, swollen extremities, pain |
Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patien...
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Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021
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| 55 | 2021-01-06 | pain |
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also ...
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Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
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| 55 | 2021-01-06 | feeling hot |
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ...
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Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
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| 55 | 2021-01-07 | pain |
At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around ...
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At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around 530 am started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol, but had headache all day. Fever did come back later in the day resolved with Tylenol. Next day fine but did have cold sores inside mouth . Head ache on 1/8 no fever or anything.
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| 55 | 2021-01-07 | pain |
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o...
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Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
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| 55 | 2021-01-07 | dizziness, pain, restlessness | By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless |
| 55 | 2021-01-07 | pain | Chil,bodyache, headache upset stomach |
| 55 | 2021-01-07 | pain in extremity |
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph...
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Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
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| 55 | 2021-01-07 | migraine, pain |
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain...
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Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
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| 55 | 2021-01-07 | tingling |
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,...
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Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
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| 55 | 2021-01-07 | pain |
Headache; Body aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-ol...
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Headache; Body aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscular (hope it was IM, but did not know for sure because she was not watching) at right arm deltoid on 29Dec2020 08:40 at single dose for COVID-19 immunization, at the hospital where she works. The vaccine was not administered at military facility. The patient's second dose was scheduled to be 19Jan2021. The patient's medical history included potassium low, hypertension, pericarditis, asthma, herniated disc in back, pain, gastrointestinal infection (GI), Vitamin D low, wheezing, exposed to someone who was positive with COVID at a wedding on 28Dec2020, "diuretic", "cardiac/heart" and "Cholesterol". Concomitant medication included ranolazine (RANEXA) for heart, isosorbide for cardiac, potassium chloride for potassium Low, furosemide for diuretic, atorvastatin (LIPITOR) for cholesterol, acetylsalicylic acid (ASPIRIN) for cardiac, montelukast sodium (SINGULAIR) for asthma, pregabalin (LYRICA) for herniated disc in back take for pain, nebivolol hydrochloride (BYSTOLIC) for blood pressure, pantoprazole sodium sesquihydrate (PROTONIX) for GI, celecoxib (CELEBREX) for pain, spironolactone for diuretic, vitamin D for Vitamin D low, nitroglycerin for angina, salbutamol (ALBUTEROL) for wheezing, and oxycodone for pain; all ongoing. History of all previous immunizations with the Pfizer vaccine considered as suspect was reported as none. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. The patient reported events on the Pfizer COVID Vaccine. She reported after getting the vaccine she had body ache and headaches. On 30Dec2020 16:00, the patient experienced headache and body aches. The event headache was reported as serious medically significant. She received the COVID vaccine on 29Dec2020 and had significant body aches, but she still had a headache that had not gone away since she got the vaccine. The patient explained the body aches were mild to non-existent/resolved, later confirmed as still ongoing, but better. Her main issue was the headaches that had not gone away. The events headache and body aches started around 16:00. She worked nightshift and she woke up with it. The events did not require a visit to the emergency room or physician office. The day after she received the COVID Vaccine she was tested for COVID. She found out she was exposed the day before she received the COVID vaccine, 28Dec2020 to someone who was positive with COVID at a wedding. She later found out her COVID test on 30Dec2020 was negative. The reporter assessed both events headache and body aches as related to the suspect vaccine. She believed the body ache and headache were related to the COVID Vaccine itself. She added, she felt it's related because these events are not part of her typical health problems. She added they're not going away even with medications (oxycodone, Celebrex, and ibuprofen). Oxycodone was located in an orange pharmacy filled bottle and she was unable to provide a lot/exp/NDC. Celebrex was located in an orange pharmacy filled bottle and unable to provide a lot/exp/NDC. She saw a use by date of 10Mar2021. Ibuprofen (Lot number: OCE2824A and expiration date: Dec2021). The outcome of the event headache was not recovered, for the event body aches was recovering.; Sender's Comments: There is a reasonable possibility that the event headache was related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-07 | numbness, tingling |
Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then ...
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Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then to left hand and left arm. Benedryl PO 25mg given at 12:05pm. No changes after Benadryl given.
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| 55 | 2021-01-07 | pain in extremity |
Recipient reported having chills overnight and reported to work today with left arm to left flank so...
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Recipient reported having chills overnight and reported to work today with left arm to left flank soreness. She took Motrin
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| 55 | 2021-01-07 | pain, feeling hot |
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ...
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Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
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| 55 | 2021-01-07 | migraine |
VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea...
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VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea.
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| 55 | 2021-01-07 | pain |
at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shive...
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at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shivers that last over an hour. Fever of 101.5 at 1am in the morning. Head ache that was first in the temples and then went behind the eyes. Water had a metal taste to it. Did not take a tylenol or anything to relieve the fever or ache. I prefer to allow my body to fight it naturally. Used an ice pack at the nap of my neck to help with fever and also headache. Also took 2 showers to help with body ache. 1/8/21 12:20pm fever is still 100.4. Body is still achy with slight headache.
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| 55 | 2021-01-07 | pain in extremity, dizziness, pain, lethargy, weakness |
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si...
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left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
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| 55 | 2021-01-07 | weakness, tingling, pain |
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type ...
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usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
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| 55 | 2021-01-07 | dizziness |
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ...
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within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
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| 55 | 2021-01-08 | vertigo | 1/08 12pm- Diarrhea 11pm- Nausea throughout the night 1/09 6am- Vertigo |
| 55 | 2021-01-08 | pain | 2 inch red area around injection, fever, aches, fatigue, headache Taking tylenol and ibuprofen |
| 55 | 2021-01-08 | dizziness |
Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. ...
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Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. Headache unresolved even after taking headache med, ibuprofen, oxycodone. Nausea and dizziness is intermittent.
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| 55 | 2021-01-08 | pain, pain in extremity |
Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fe...
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Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fever. Her left arm is also very painful. 12/31 - symptoms resolved.
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| 55 | 2021-01-08 | pain in extremity, dizziness, pain |
Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills ...
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Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills and dizziness starting 10 hours post injection and persist entire next day.
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| 55 | 2021-01-08 | pain |
fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 d...
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fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 days
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| 55 | 2021-01-09 | pain | Cough, body aches, headache |
| 55 | 2021-01-10 | tingling |
1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2...
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1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2021 (thought due to wearing mask?) 1/9/21 soreness & heat to injection site - joint pain esp. hands, elbows and wrists; and flu-like symptoms - tired 1/10/21 little redness to site-swollen/soreness & heat still ; joint pain in fingers still not so much in main joints 1/11/21 finger joint pain - lot of redness/soreness/heat/swollen to site of injection ** new symptom sharp pinching pain around site
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| 55 | 2021-01-10 | pain | Fever, chills, headache, body aches, nausea |
| 55 | 2021-01-10 | pain |
Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache...
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Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache and fatigue are persisting.
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| 55 | 2021-01-10 | numbness |
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B...
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Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
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| 55 | 2021-01-10 | dizziness |
Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not sub...
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Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not subside after 30 minute observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | dizziness |
Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not su...
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Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not subside after 30 minutes of observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | pain |
The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I ...
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The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I broke my wrist last year and the ache in that wrist was awful. Motrin helped but this persisted throughout the day. General feeling of being unwell for the whole day and evening. The second day after the shot I woke up feeling better but in my armpit on the arm I received the shot it felt like I had a lump in my arm pit and it is sore. This is still there today, the third day after the shot.
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| 55 | 2021-01-10 | lethargy, weakness | Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site |
| 55 | 2021-01-10 | pain in extremity, pain |
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du...
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lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
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| 55 | 2021-01-10 | pain, pain in extremity | localized redness at injection site, R arm/hand joint tenderness and pain, over 72 hr. period |
| 55 | 2021-01-10 | numbness | pt reported bilateral arm numbness and was diaphoretic at 0904 |
| 55 | 2021-01-11 | tingling, numbness |
Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later ...
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Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg. I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you
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| 55 | 2021-01-11 | pain |
HEADACHE STARTED 17 HOURS POST VACCINATION TOOK TYLENOL,IBUPROFEN AND FIORCET (IT WENT AWAY 24 HRS L...
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HEADACHE STARTED 17 HOURS POST VACCINATION TOOK TYLENOL,IBUPROFEN AND FIORCET (IT WENT AWAY 24 HRS LATER). BODY ACHES STARTED 29 HOURS POST VACCINATION (WENT AWAY 48 HOURS POST VACCINATION) FEVER 100.4 AND CHILLS STARTED 52 HRS POST VACCINATION AND WERE GONE BY 36 HOURS.
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| 55 | 2021-01-11 | pain | Headache, Body Aches, Chills, Fatigue |
| 55 | 2021-01-11 | pain | Headache, nausea, chills, Body aches |
| 55 | 2021-01-11 | dizziness |
PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOM...
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PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOMS RESOLVED
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| 55 | 2021-01-11 | pain in extremity |
began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid ...
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began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; Arm was sore; This is a spontaneous report from a contactable physician reported for herself. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination. Medical history was not reported. There were no concomitant medications. Patient had arm sore on 18Dec2020. She started having COVID symptoms on 24Dec2020. She tested positive on Christmas, 25Dec2020. She was asking if she should get the second vaccine. When she got the vaccine she didn't pay attention to the paperwork. She was busy. Her arm was a little sore for a day that was the only reaction she had. She was hoping when she developed COVID symptoms that she was not sick. She was not hospitalized, and she is wondering if maybe the vaccine helped her not get as sick, and not end up in the hospital. It was the first dose she received. She has no other medical conditions. All the previous agent did was read off information to her. It sounds to her like she should go ahead and get the second dose. Outcome of event Arm was sore was recovered in 19Dec2020, of others was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be completely excluded for reported events.
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| 55 | 2021-01-11 | dizziness |
headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report fr...
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headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 55 | 2021-01-12 | pain in extremity, pain, tremor |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-12 | weakness |
After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weake...
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After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weakeness hit me and I had to sit on toilet. I was unable to move my arms or legs for 20 minutes, then was able to get up but walked VERY WOBBLY AND WEAK to my bed just a few feet away. I collapsed on my bed and turned my fan blowing on me directly. {Im NEVER hot, usually cold ALL the time}. I layed there so weak I could barely move for another 20 to 30 minutes. I thought I was having a stroke honestly and my thoughts were about my doors being locked so nobody could get in to help me and my phone was in the living room and for that time period I WAS TOTALLY UNABLE to go get it. THANKFULLY, after about 45 minutes total, all symptons went away and I returned to my baseline mobility. Im very grateful that this was not a stroke as I thought. but I do believe it may have been a reaction to the vaccine. I did not notify any physicians yet, and as of this writing Im perfectly fine, Thank the Lord.
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| 55 | 2021-01-12 | pain | Body aches, chills |
| 55 | 2021-01-12 | pain in extremity | Chills Very sore arm |
| 55 | 2021-01-12 | pain | Chills, fatigue,full body aches, abdominal pains |
| 55 | 2021-01-12 | pain | Fever, body aches. |
| 55 | 2021-01-12 | lethargy | Lethargic Muscle fatigue |
| 55 | 2021-01-12 | tingling, numbness |
The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injec...
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The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injection site and I noticed that the skin in my left flank, left back and Left abdomen felt numb. On Day 2 1/12/21, the numbness got progressively worse and it was noted that there was a marked difference while showering, my upper left hip and thigh were also beginning to get numb. I went into the ED where they took x-rays, gave me steroids (Decadron) and sent me home for follow up within the next 3-5 days. Today, Day 3-1/13/21,My skin still feels numb and less, and the tingling in my left thigh is no longer present. dx"paresthesia," no other concerns as it has not affected my movement or ability to work.
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| 55 | 2021-01-12 | numbness |
Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Loca...
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Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Location of numbness is in the area of the Right temple upper cheek bone easing toward ear. By 2:00 pm that day was experiencing a dull headache centering on my temple. I went home from work to lie down. The headache and numbness lasted into the next day. At the time of this report 8:57 pm on 1/13/21 the numbness is still there.
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| 55 | 2021-01-12 | pain | chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw |
| 55 | 2021-01-12 | pain |
headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontan...
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headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for work. The patient's medical history and concomitant medications were reported as none. The patient reported events of fever, headaches, body aches, joint pain, tachycardia, on 07Jan2021. Patient developed fever in the night, 100.5 at 1-3 am. Then, developed body ache and especially joint ache. She had a bad headache from 2-3 am. She also experienced a fast heart beat that started around 2-3 am. She received the vaccine at work. She started taking the paracetamol (TYLENOL) which did pushed down her fever. She thought it helped her headache as well and it helped her heart rate. Her headache was controlled with paracetamol. So she could not tell if it was improving, persisting, or worsening. Her heart rate at around 2-3 am was 115bpm, after paracetamol it got down to 105 bpm. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events fever and tachycardia was recovering, outcome of event headaches was unknown, outcome of the other evets was not recovered. The report was reported as non-serious.
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| 55 | 2021-01-12 | migraine | migraine with mild vomiting resolved by morning with medications |
| 55 | 2021-01-12 | tingling, numbness |
to develop a rash yesterday. It started off as large red spots last night, and this morning they are...
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to develop a rash yesterday. It started off as large red spots last night, and this morning they are smaller red spots. She said the rash started in her feet and is moving upwards. This morning it is now on her arms. She also said she was having numbness and tingling from the waist down as well. Last night she did take Benadryl. She is not experiencing any other side effects. She did not have this reaction after the first dose. prednisone, benadryl given at urgent care, prescription for prednisone given at Urgent Care
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| 55 | 2021-01-13 | tremor | Awakened severe shortness of breath, chills, muscle shakiness and pain, nausea, vomiting |
| 55 | 2021-01-13 | pain in extremity |
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, requi...
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Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
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| 55 | 2021-01-13 | pain |
Body ache; This is a spontaneous report from a contactable nurse (patient) via Pfizer sponsored prog...
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Body ache; This is a spontaneous report from a contactable nurse (patient) via Pfizer sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EJ1686, via an unspecified route of administration on 05Jan2021 at a single dose to prevent getting Covid. The patient's medical history and concomitant medications were not reported. The patient received the covid vaccine about 24 hours ago and was now having a body ache (unknown date in Jan2021) with outcome of unknown. She was wondering if she can take Tylenol or Advil or something to help that. The patient did not receive any treatment for the event.
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| 55 | 2021-01-13 | feeling hot |
During the early morning following my second Covid vaccination, I started having fever and chills, m...
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During the early morning following my second Covid vaccination, I started having fever and chills, muscle aches, and a headache. I woke up about 230 am and my stomach was hurting. I thought I would have to have a bm in a little while but was able to go back to sleep. About an hour and a half later, I again woke up with stomach pain, maybe some bloating. I decided to go into the bathroom and I sat on the floor beside the toilet and began vomiting. I vomited 5 times and had one dry heave. The vomitus was clear in color, thin with some small pieces of food. I had felt very hot before vomiting, but was unable to check my temperature due tp nausea and vomiting. I checked my temperature a little while later and it was 100.2 F. I was able to go back to sleep for a while and kept checking temperature during the day. It was between 99.1 and 99.8 for most of the day.
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| 55 | 2021-01-13 | pain in extremity |
Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; mu...
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Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-13 | pain | Fatigue, Headache, Body aches |
| 55 | 2021-01-13 | tingling, feeling hot |
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d...
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I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
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| 55 | 2021-01-13 | pain in extremity |
I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full fron...
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I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full front and back body rash that afternoon. It started spreading up my neck and onto my forehead. No other symptoms. I took 25mg of Benadryl that evening. Woke up the next day with improving rash but still visible.
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| 55 | 2021-01-13 | tingling |
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu...
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Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
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| 55 | 2021-01-13 | pain |
chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a conta...
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chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-14 | dizziness, tingling |
About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by fee...
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About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by feeling dizzy and wobbly. Must hold onto something to walk. Has some trouble focusing, "like a fog".
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| 55 | 2021-01-14 | pain |
Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a histor...
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Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a history of shingles in 2011. I received the 2 dose shingles vaccine in 2019. I received my second Pfizer dose on 1/11. Developed fatigue and muscle aches on 1/12, then slight headache, muscle weakness, myalgia's and arthralgia on 11/13. Morning of 11/14, woke up and noticed a sore spot/blister on my lower/mid back area. Slowly became more painful (burning sensation). No injury to area or any other reason for blister and pain. 11/15, realized it was shingles.
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| 55 | 2021-01-14 | pain |
Headache with sharp shooting pains in temples, chills, low grade fever 100.6, body aches especially ...
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Headache with sharp shooting pains in temples, chills, low grade fever 100.6, body aches especially knees
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| 55 | 2021-01-14 | tingling, inability to speak |
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ...
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Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
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| 55 | 2021-01-14 | pain |
Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report...
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Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
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| 55 | 2021-01-14 | dizziness |
Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of t...
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Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of the vaccine. The patient had expressed some anxiety about receiving the vaccine but wanted to receive it. The patient complained of lightheadedness and we lowered her to the floor with feet elevated. Her blood pressure had lowered significantly (60/40 approximately). Patient began to feel better and sat back in her chair. She again began to complain of lightheadedness and was lowered to the floor with feet elevated once more. Patients stayed in this position for several minutes. When her blood pressure was rechecked, it had risen back to 118/78. Patient felt much better and also ate some crackers and drank some water. Patient's blood pressure was checked a final time in a seated position after approximately 20 minutes and her blood pressure was 118/82. Patient reported having an event like this 36 years ago after her first visit to an OB/GYN and was similarly nervous that day. Patient was counseled extensively on preventing future lightheadedness and signs of any vaccine related adverse event. After approximately 45 minutes of observation from the event, patient was driven home by her husband.
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| 55 | 2021-01-14 | pain, pain in extremity |
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r...
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Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
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| 55 | 2021-01-14 | pain |
Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with fro...
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Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with frozen finger tips. Could not warm them up. Continued fatigue and febrile and malaise.
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| 55 | 2021-01-14 | dizziness |
flu-like symptoms; dizziness; heavy feet; This is a spontaneous report from a contactable pharmacist...
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flu-like symptoms; dizziness; heavy feet; This is a spontaneous report from a contactable pharmacist reporting for herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9231), via an unspecified route of administration on 07Jan2021 13:45 in left arm at single dose for COVID-19 immunization. Medical history included allergies to cherries and hazelnuts amd Hashimoto's thyroiditis from an unknown date and unknown if ongoing; h/o possible GBS (Guillain-Barre syndrome) from an unknown date and unknown if ongoing post influenza vaccine in 2016. Concomitant medication included fish oil, minerals nos, quercetin, thioctic acid, vitamins (EMERGEN-C) and multivitamins. On 08Jan2021, the patient experienced flu-like symptoms and bouts of dizziness, and a feeling of "heavy feet" 24 hours post administration of BNT162B2. No treatment was given to the patient for the events. The outcome of the events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 55 | 2021-01-15 | unresponsive to stimuli, weakness |
Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At ...
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Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like "not now, I want to go to lake"), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.
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| 55 | 2021-01-15 | pain, migraine |
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig...
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Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
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| 55 | 2021-01-15 | numbness, pain, dizziness |
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin...
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The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
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| 55 | 2021-01-15 | pain |
fatigue, headache, body aches. sx severe in am (day after vaccine) , improved by the evening. none ...
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fatigue, headache, body aches. sx severe in am (day after vaccine) , improved by the evening. none by the next day.
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| 55 | 2021-01-16 | pain, dizziness |
I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such a...
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I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awake with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pan. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way
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| 55 | 2021-01-16 | dizziness, tingling |
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se...
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I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
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| 55 | 2021-01-17 | pain, dizziness, feeling cold |
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac...
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12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
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| 55 | 2021-01-19 | pain | Aches and chills for 24 hours. Flu like symptoms. |
| 55 | 2021-01-19 | pain |
Chills and headache beginning approximately 2 hours after injection. Proceeding to full body aches,...
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Chills and headache beginning approximately 2 hours after injection. Proceeding to full body aches, fever to 103, sweats and mild nausea over next 24 hours. Symptoms mitigated by use of Ibuprofen. 48 hours post vaccine, symptoms are resolving - minor headache and sweats remain. Afebrile.
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| 55 | 2021-01-19 | dizziness |
Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past m...
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Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past medical history no surgical history.
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| 55 | 2021-01-19 | numbness, tingling |
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observ...
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I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area. After release I went to my car and started to drive home. At the 25 minute mark post vaccine (1:55pm) I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing). I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse. After 10 minutes symptoms subsided and I continued home. At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes. No further side effects.
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| 55 | 2021-01-19 | numbness | Transient numbness and tingling of left cheek lasting 7 minutes. No allergic signs or symptoms. |
| 55 | 2021-01-19 | pain |
on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and i...
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on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30 I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.
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| 55 | 2021-01-20 | pain |
several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chi...
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several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E. On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-21 | pain |
1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SO...
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1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SORENESS AT INJECTION SITE. TOOK TYLENOL 7AM 1/20.
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| 55 | 2021-01-21 | weakness, pain |
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot...
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Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
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| 55 | 2021-01-21 | pain | Body aches, headache, chills |
| 55 | 2021-01-21 | pain | Extreme cold chills, body aches and trouble breathing |
| 55 | 2021-01-21 | pain | FEVER 101 FOR 24 HRS/ BODY ACHES/ VOMITING/ TOOK ACETAMINOPHEN. |
| 55 | 2021-01-21 | tremor |
High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shakin...
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High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shaking like a seizure. I was extremely confused I had a 8/10 headache. I had serve fatigue. This last about 24 hours then went away I finally got out of bed the next day about 4:30PM.
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| 55 | 2021-01-21 | pain | SORE THROAT, CONGESTION, FUNNY FEELING IN CHEST (UNSURE HOW TO DESCRIBE), TEMP 99-100, MILD ACHINESS |
| 55 | 2021-01-21 | swollen extremities |
Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at th...
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Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at this time) Fever 100.5-100.9 x 30 hours Severe muscle and bone aching x 36 hours Chills x 18 hours
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| 55 | 2021-01-24 | weakness | Extremely week, extreme muscle pain, temp over 100 degrees farenheit |
| 55 | 2021-01-24 | dizziness |
I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt lik...
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I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt like I had flu, chills, nausea, stomach cramps, muscle pain, joint pain. I had some insomnia. I had this for about 3-4 days after. I started feeling better on Saturday and got the vaccine on a Tuesday. I spoke to my Dr. about it and we decided to take Tylenol and a lot of baths.
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| 55 | 2021-01-24 | dizziness |
I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and d...
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I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and diaphoretic while i was at work. i continued to work and didn't go home until close to 4pm, i thought it would go away like the first time but it didn't, i went home and laid down and took a zanax and it didn't go away. the next morning i went to the ER and they put me on a telemetry monitor and i was having bigeminy and palpitations and i thought my heart was going to come out of my chest and was hurting they gave me 4mg of morphine, 2 hrs they gave me more morphine, i was nauseated they gave me Zofran then it finally subsided later but till had bigeminy and chest pressure, they admitted me and i stayed overnight. i had the PVC and bigeminy slowed down i had an echo and it was normal the potassium was low and they gave me kedar, i was still ight headed and nauseated they gave me Zofran prn it was 4-5 doses they gave me IV fluid, my fever with up to 100.4, i was not really eating that 24 hrs because i was afraid to throw up. the doctor gave me meds to take home to manage light symptoms . i went home and felt tired and had more palpitations when i move around too much and I'm still having issues today. i have not gone back to work since the vaccination and have an appointment with cardiologist 2:pm tomorrow and today I will see my PCP at 1pm. I have not recovered and still having issues and very tired.
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| 55 | 2021-01-24 | pain, lethargy, pain in extremity |
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S...
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On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
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| 55 | 2021-01-24 | pain |
The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Th...
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The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters. Just skin sensitivity . I was prescribed triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
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| 55 | 2021-01-24 | feeling hot |
Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the fac...
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Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the face and saying it was getting hot. Then, continued to cough and was using her prescribed inhaler ( unknown what type of inhaler it was ). Administered epi-pen immediately, and called 9-1-1. Had to administer second epi-pen 5 minutes later, and patient also took two 25 mg benadryls. A nurse at the facility was the one to administer her epi-pens. They were the patient's prescribed epi-pens
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| 55 | 2021-01-25 | pain, feeling of body temperature change | Body aches, hot and cold. |
| 55 | 2021-01-25 | pain | Muscle - body aches, bad headache, lower back pain, tired arm shot area pain |
| 55 | 2021-01-25 | numbness |
Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This...
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Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), intramuscularly on 07Jan2021 08:15 at right arm, at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included omeprazole, potassium gluconate; oenothera biennis oil (EVENING PRIMROSE); ascorbic acid (VIT C); glucosamine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously took clarithromycin (MACROBID) and known allergies was Macrobid. The patient was not pregnant at the time of vaccination. The patient experienced right arm numbness and discomfort when raising at shoulder level and above on 12Jan2021. No treatment was received. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 55 | 2021-01-25 | feeling cold, dizziness, tenderness |
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ...
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Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-01-25 | tremor, weakness |
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun...
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When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
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| 55 | 2021-01-25 | pain | fever/chills, body aches |
| 55 | 2021-01-26 | pain in extremity |
1/26/21 at 6:30 am patient woke up and noticed that her left fifth digit felt like an electric shock...
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1/26/21 at 6:30 am patient woke up and noticed that her left fifth digit felt like an electric shock pain when making a fist. Pt. states that she took tylenol for the pain and did not get relief. Pt. states that her left fifth digit is still painful 8-9/10. Pt. states that she is currently working now, and she is trying to be cautious of her left fifth digit pain so that she does not trigger the pain.
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| 55 | 2021-01-26 | tingling |
About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sens...
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About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sensation, as if it were 'asleep'. Sensation not relieved by anything, not worsened by anything. Patient said it was more a nuisance than anything. Advised by clinic staff that might be nerve issue related to the injection itself. She said she would not want to go to the ER but would follow up with her primary care doctor if issue persisted.
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| 55 | 2021-01-26 | pain in extremity |
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoul...
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Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
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| 55 | 2021-01-26 | dizziness |
dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is ...
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dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-26 | pain, pain in extremity |
had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...w...
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had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...woke up at 5:00 this morning (day after shot) with horrible pain from shoulder all the way to finger tips....fell back asleep, woke again at 7:30 with the same symptoms got up and tried moving the arm (with pain) went ahead and used arm and read reactions and what to do...tried to use arm, after about 1 hour of trying to use arm the pain is just over the injection where there is a grapefruit size hard spot with intense pain. Will continue to try to move the arm and use cold compresses and drink water as the organization site suggested. Pain is not just in upper arm with majority of pain in that grapefruit size area.
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| 55 | 2021-01-26 | pain in extremity |
mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soren...
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mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Workplace clinic. Medical history included obesity from an unknown date. Known allergies included sulfa and penicillin. Concomitant medication included metoprolol, vitamin d3, calcium, probiotics. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild metallic taste on 22Dec2020 11:30 with outcome of recovered, arm soreness on 21Dec2020 with outcome of recovered, poor administration tech on 21Dec2020 11:40 with outcome of recovered, extreme burning for 10 min following vax-i on 21Dec2020 11:40 with outcome of recovered. The verbatim as follow: 1st Vax: mild metallic taste and arm soreness (including extreme burning for 10 min following vax-I believe this was poor administration tech), slight metallic taste 24 hrs post vax, lasted a few hours. Patient didn't receive treatment for the adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Jan2021. The covid test type post vaccination was Nasal Swab. The covid test name post vaccination was PCR.
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| 55 | 2021-01-27 | pain in extremity |
Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontane...
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Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol. The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered. Information of lot/batch number has been requested.
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| 55 | 2021-01-28 | dizziness |
Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like ...
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Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like her skin was on fire. She also reported some tingling of her tongue and throat. She was administered Benadryl PO x 1 dose and monitored for approximately 60 minutes. Her symptoms improved and she left in improved condition.
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| 55 | 2021-01-28 | dizziness | had dizziness 15 minutes after vaccine. orthostatic BP taken and were negative |
| 55 | 2021-02-01 | tremor | Shaking , burning in arm, leg chest face, rapid heart rate |
| 55 | 2021-02-02 | pain, tenderness, pain in extremity |
Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for...
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Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.
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| 55 | 2021-02-03 | feeling hot, pain, difficulty speaking |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-07 | tingling, pain, weakness, numbness |
I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it wa...
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I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: "like when you get an injection for dental work." It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.
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| 55 | 2021-02-07 | pain in extremity |
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib...
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symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
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| 55 | 2021-02-21 | tremor | 2) "Stoned" From 8:15pm 2/5 thru 12:00 pm 2/7 1) Sporadic vibration of entire body 3) Constipation |
| 55 | 2021-02-21 | lethargy |
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little...
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Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
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| 55 | 2021-02-21 | pain in extremity |
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H...
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FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
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| 55 | 2021-02-21 | pain, tingling |
Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wr...
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Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wrist. The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days. But the wrist pain has been getting worse, and consistent. I broke that wrist 10 yrs ago, and may have some slight work related carpel tunnel. With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine. I just received the second dose 3 days ago, and still my wrist is hurting. I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace. I am currently waiting to see my primary care doctor to seek medical attention.
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| 55 | 2021-02-21 | dizziness | dizziness |
| 55 | 2021-02-22 | pain in extremity, feeling cold, dizziness | Sore arm, headache, dizzy, tired, chill. a little fever, from 6 hrs to 40 hrs after dose. |
| 55 | 2021-02-23 | feeling hot |
3 days after vaccination I started to have intermittent localized "heat" sensation in right side o...
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3 days after vaccination I started to have intermittent localized "heat" sensation in right side of skull. It would only last for a short time, a minute or two, maybe a little longer and then disappear. It was an intense heat feeling but with no pain. I was sitting quietly doing a puzzle. Because of the weekend unable to contact Dr and on call Dr did not respond to my callback request. Monday 2/15/21 talked to Dr and he it's not a vaccine reaction and it'll go away. This continued occasionally for a few days until day 5 and 6 the heat sensation increased and duration of event was much longer, lasting most of the day with short time spans between episodes. Heat sensation moved from right side of skull to top of head and was very intense, having to use a icepack for some relief. Called Dr a second time and told me to wait it out and call him next week to report status. By day 7 there is a mild headache but intensity of the heat sensation in skull has decreased to milder and less frequent again. Day 13 symptoms were almost completely resolved but by 14/15 they have returned though milder than worst symptoms were. I called Dr's office on Friday 2/19 and they said to call back next week if symptoms do not get better will refer to nruology.
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| 55 | 2021-02-23 | lethargy |
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
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| 55 | 2021-02-23 | pain |
achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. ...
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achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248), via an unspecified route of administration on the left arm at the age of 55 years, on 09Feb2021 16:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C) and Multi Vitamin. The patient had the first dose last 20Jan2021. The patient experienced achiness, low grade fever 100.6 and fatigue on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 100.6 on 10Feb2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date.
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| 55 | 2021-02-24 | pain |
Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report f...
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Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration left arm single dose on 10Feb2021 15:00 for covid-19 immunisation. The patient received the first dose on 20Jan2021 lot#lEL9263. The patient medical history was not reported. No other vaccine was received in four weeks. The patient's concomitant medications were not reported. The patient experienced headache on 11Feb2021 12:00, body aches on 11Feb2021 12:00, neck and shoulder pain on 11Feb2021 12:00. No treatment received. The events recovered in Feb2021 No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-02-28 | pain in extremity |
sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour l...
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sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
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| 55 | 2021-03-01 | pain in extremity |
Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm p...
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Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection. This pain was severe visceral pain and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg. I need to take ibuprophen to decrease the discomfort.
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| 55 | 2021-03-02 | pain |
Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable ...
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Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 11:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After dinner of 30Jan2021, the patient started having symptoms listed as headaches, chills, nauseated, and body aches. She described her chills as being so bad that she woke up last night shivering. She said the nausea and body aches come and go. She asked how long will her symptoms last. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-03-06 | numbness, tingling | Feet and leg hands arms back. Pins and needles numb |
| 55 | 2021-03-07 | pain |
white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore th...
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white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7. Concomitant medication included dimethyl fumarate (TECFIDERA). The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation. A week after the patient got the vaccine, she had a sore throat, chills and body aches. The patient just went to bed early and was fine. The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low. The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine. The patient haven't had this shift before in lymphocyte and neutrophil count. On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-03-08 | dizziness |
dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professio...
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dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an unspecified route of administration on 02Feb2021 at 07:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included COVID-19 infection on an unspecified date. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as "No." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:00, the patient experienced dizziness and nausea. The reporter commented that she did not think these were side effects from the vaccine because she got it on Tuesday but her husband pointed out that she normally does not have these side effects, so it has to be from the vaccine. The clinical outcomes of the events dizziness and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-03-10 | weakness |
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil...
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extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-22 | difficulty speaking |
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ...
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- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
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| 55 | 2021-04-07 | tingling, tremor, numbness |
Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient co...
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Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient complained uncomfortable numbness tingling in her arms and legs on 4/3. Was admitted to medical center on 4/5.
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| 55 | 2021-04-07 | tingling |
Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started a...
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Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started about 24 hours after receiving the vaccine. These symptoms resolved by day three. However, she started developing parasthesias in her feet and pain in left hip. Patient came to hospital on 4/5 after symptoms worsened. In hospital, patient received an LP and GBS was ruled out and was discharged with patient still complaining of burning of her feet and hands.
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| 55 | 2021-04-13 | facial paralysis, inability to speak |
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her ri...
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The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
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| 56 | 2020-12-31 | dizziness |
Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores o...
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Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores on tongue, lips swollen later in day and next day. No breathing issues.
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| 56 | 2020-12-31 | pain in extremity, dizziness |
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m...
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Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
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| 56 | 2020-12-31 | dizziness |
patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor t...
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patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor that was working vaccination clinic. instructed to take tylenol. No further intervention required.
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| 56 | 2021-01-02 | pain |
BioNTech Covid-19 Vaccine I experienced sudden severe chills lasting 2-3 minutes. I also had extrem...
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BioNTech Covid-19 Vaccine I experienced sudden severe chills lasting 2-3 minutes. I also had extreme elevation of pain to my injured knee from a 5 to 10+ during this episode. The chills resolved spontaneously.
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| 56 | 2021-01-03 | pain in extremity |
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe...
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Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
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| 56 | 2021-01-03 | pain | Headache Chills Temp (101.6) Body aches Skin hurts to touch Soreness in arm (injection site) |
| 56 | 2021-01-03 | weakness |
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ...
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Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
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| 56 | 2021-01-03 | pain |
This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a ...
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This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a possible reaction to the COVID vaccine onset 2 days ago. The patient states that she has had a fever, chills, adenopathy, and body aches since her vaccination. Her highest recorded temperature was 101F, and she has been taking Tylenol. She states that her biggest concern is the adenopathy under her right armpit which is painful to touch. She denies any masses. She saw her PCP on 12/24 and had blood work done, which showed an elevated white count of 17.
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| 56 | 2021-01-03 | tingling |
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,...
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Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
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| 56 | 2021-01-04 | pain |
Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient...
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Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient). A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration at right arm on 17Dec2020 13:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Relevant medical history and concurrent conditions was reported as "Structured information (Patient episode name): Fibromyalgia, tachycardia, shingles, breast cancer". Patient was diagnosed with COVID prior to vaccination. Patient known allergies included Codeine, morphine sulfate (Duramorph) and Sulfa. Concomitant medication included metoprolol succinate (TOPROL), alprazolam (XANAX) and desvenlafaxine succinate (PRISTIQ) received within 2 weeks of vaccination. No other vaccine in four weeks. Adverse events were reported as "Started day after shot. Aching all over headaches. Broke out in shingles 7 days later". Adverse event start date was reported on 24Dec2020. No treatment received for the events. since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 56 | 2021-01-04 | pain | DEVELOPED CHILLS, BODY ACHES, AND FATIGUE. LASTED APPROXIMATELY 24 HOURS BEFORE RESOLVING. |
| 56 | 2021-01-04 | pain |
Headache; Chills; just really tired; achy; This is a spontaneous report from a contactable consumer....
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Headache; Chills; just really tired; achy; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2; reported as Covid Vaccine Pfizer; batch/lot number: EH9899; expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 vaccination. Medical history included AFib (atrial fibrillation), high blood pressure and has 25 percent of her colon. The patient's concomitant medications were not reported. The patient reported that she a Pfizer shot yesterday (28Dec2020) which was clarified as Covid Vaccine Pfizer and today (29Dec2020) she was having some reactions to it, but they are not serious. The patient mentioned that she has like a headache and some chills and something like that which she hoped would go away by tomorrow (30Dec2020) and hoping that it doesn't last long. The patient mentioned that this was her first dose. When inquired on treatment, the patient mentioned that she was just really tired and achy and was just going to try sleep. The patient underwent lab tests and procedures which included Covid Rapid testing every single week [unspecified date] but no results were provided and last time she was tested was on last Tuesday (22Dec2020) with negative results. The outcome of the event headache and chills were not recovered while the outcome of the other events was unknown.
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| 56 | 2021-01-04 | dizziness |
Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel righ...
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Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.
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| 56 | 2021-01-04 | tingling, numbness, dizziness |
Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had he...
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Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had her blood pressure taken. It was 171/105. Stated that she had not taken her morning blood pressure medications (lisinopril 10mg and atenolol 50mg). The nurse at the facility gave her a dose of lisinopril 10mg. Patient then stated prickly, numb feeling and foggy-headed. The facility then gave her 2 doses of diphenhydramine 25mg. At approximately 11am, patient was still not improving and felt like she was getting worse. The facility then called for an ambulance to take her to the ER for assessment.
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| 56 | 2021-01-04 | dizziness, weakness |
Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and abou...
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Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am. Ondansetron 4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am. Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
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| 56 | 2021-01-04 | pain in extremity |
Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A...
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Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, via an unspecified route of administration, in the left arm, from 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included allergies to penicillin, gluten, chicken eggs (whites & yolks) and cow's milk. Patient was not pregnant. The patient's concomitant medications were not reported. on 23Dec2020 09:00, after being vaccinated, the patient experienced sore left arm for 2-3 days. The patient underwent lab tests and procedure on unspecified date which included Nasal Swab test/COVID test, yielding negative result. The outcome of event was recovered on Dec2020. Follow-up attempts are completed. Information on the batch/lot number has been obtained.
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| 56 | 2021-01-04 | vertigo | Vertigo, nausea, vomiting |
| 56 | 2021-01-04 | pain in extremity |
soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. ...
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soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. A 56-year-old female nurse received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization on right arm.Relevant medical history included ongoing osteoarthritis and high cholesterol. Concomitant medications included atorvastatin calcium (LIPITOR ORIFARM), escitalopram oxalate (LEXAPRO) and pantoprazole. On 28Dec2020 at 07:00 PM patient started experiencing soreness in arm when using arm or to touch. At the time of the reporting the patient was recovering from the event.
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| 56 | 2021-01-05 | feeling cold, pain |
"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt co...
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"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt cold no fever went to bed and rigors subsided after 20 minutes. Body did ache overnight and headache developed. Took Tylenol with some relief. In am aches and rigors remained absent but still had dull headache. Took headache medicine and otherwise felt fine. I have a history of feeling like this in the past after receiving my flu shot."
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| 56 | 2021-01-05 | pain |
Chills, body aches began about 12 hours after injection. Side effects lasted approximately 24 hours....
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Chills, body aches began about 12 hours after injection. Side effects lasted approximately 24 hours. Tylenol resolved side effects for about 3 hours after taking it. Had to wait additional time to take more.
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| 56 | 2021-01-05 | pain, pain in extremity |
Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Rig...
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Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Right arm. Shoulder pain moved into and included the axilla approximately 9 hours post vaccination. During the night, approximately 16 hours after vaccination, I began to have radiating, shooting pain up both sides of my neck up into the ears. This neck pain lasted approximately 72 hours. The arm pain had resolved at approximately 30 hours. The neck pain lessened and resolved with repeat applications of heat and Ibuprofen.
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| 56 | 2021-01-05 | vertigo | Extreme vertigo, stomach pain then nausea |
| 56 | 2021-01-05 | dizziness |
Headache; Chills; Muscle ache; Dizziness; Fatigue; This is a spontaneous report from a contactable c...
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Headache; Chills; Muscle ache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Dec2020 10:30 at single dose for preventive measure of COVID. Medical history included hypertension. Concomitant medication included atenolol at 50 mg for hypertension. Consumer stated, "It is Pfizer! I am having side effects, I started this morning. I am having the headache, chills and muscle ache, just feel like I have a flu but I don't. I have received the vaccine yesterday from my job, yesterday at 10:30. I think I got all the symptoms like the dizziness, fatigue, headache and muscle ache." Consumer stated, "I just took some Aleve" as treatment. The outcome of events was unknown. Information about lot/batch number has been requested.
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| 56 | 2021-01-05 | facial paralysis, dizziness |
Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left ...
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Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.
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| 56 | 2021-01-05 | pain |
Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade ...
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Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
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| 56 | 2021-01-05 | vertigo |
Patient reports vertigo and it comes and goes since vaccine. She says the room is spinning and was u...
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Patient reports vertigo and it comes and goes since vaccine. She says the room is spinning and was unable to drive and not able to care for patients.
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| 56 | 2021-01-06 | feeling hot | "Hot, Blotchy" given Benadryl 25mg liquid, po x1 dose. Resolved |
| 56 | 2021-01-06 | pain, dizziness, pain in extremity |
2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; ...
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2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.
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| 56 | 2021-01-06 | pain in extremity, pain | Arm hurts and woke up with headache fever and body aches 12 hrs after vaccine was administered. |
| 56 | 2021-01-06 | pain in extremity, pain, dizziness |
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw...
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C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
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| 56 | 2021-01-06 | pain | Fever, body aches, and body rash on Day 2 |
| 56 | 2021-01-06 | tingling | Headache, chills, hot flashes, rash on face, feeling like "mosquito bites" all over the body |
| 56 | 2021-01-06 | tingling |
Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites...
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Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites" all over body
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| 56 | 2021-01-06 | feeling hot |
In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever...
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In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever. Probably 6-8 times per day lasting greater than 30 min. This "warmth" or "flush" feeling continues to this day. I am peri-menopausal, but have not had "hot flashes" prior to the administration of the COVID immunization.
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| 56 | 2021-01-06 | pain in extremity | Pain on injection site, turned red, swollen & hard. |
| 56 | 2021-01-06 | dizziness |
Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% R...
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Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% RA; 3:23PM BP 180-110, P 84, O2 sat 99% RA; 3:35PM BP 210/100 P88, O2 sat 98% -- > called emergency services; 4:25PM BP 140/92. Paramedics administered 1 dose 25mg diphenhydramine.
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| 56 | 2021-01-06 | pain | Patient reported fever and body aches for 8 hours |
| 56 | 2021-01-06 | pain, balance disorder, vertigo, dizziness, weakness |
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/...
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Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | dizziness, balance disorder, weakness, numbness, pain in extremity, pain, vertigo |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | feeling hot |
Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 e...
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Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 episodes throughout the day since. No treatment needed. I just wanted to report just in case .
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| 56 | 2021-01-06 | pain in extremity | arm soreness from 12/31/20 to 1/5/21. fatigue 12/31/20 to 1/4/21. |
| 56 | 2021-01-06 | tingling | headaches, hot flashes, chills, rash on face, feeling like "mosquito bites" all over body |
| 56 | 2021-01-07 | pain in extremity |
After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I bec...
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After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I became sick.
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| 56 | 2021-01-07 | pain |
Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevat...
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Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevation on EKG in ER, taken to Cath Lab- no intervention done. D/C home 12/22/20. Previous Hx of COVID per patient
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| 56 | 2021-01-07 | pain | Chills, fever, nausea, vomitting, diarrhea, and body aches |
| 56 | 2021-01-07 | pain | Fatigue, body aches, cellulitis at injection site |
| 56 | 2021-01-07 | pain | Fever 102.9, chills, body aches, pain at injection site, nausea, cough |
| 56 | 2021-01-07 | pain in extremity | Headache Fatigue, sore arm |
| 56 | 2021-01-07 | pain |
I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not t...
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I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not taste and smell and congested.
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| 56 | 2021-01-07 | tenderness | Left shoulder pain and tenderness |
| 56 | 2021-01-07 | pain |
ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOUR...
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ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOURS.
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| 56 | 2021-01-07 | dizziness, feeling hot |
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/...
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Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
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| 56 | 2021-01-07 | weakness |
Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27...
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Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27, patient started having pressure in her head and sinuses, weakness. Then she developed nonproductive cough and progressive shortness of breath. She was seen at urgent care and tested positive for COVID-19 on December 29. She had low oxygen saturation on home oximeter and severe shortness of breath. Patient's husband is also ill with COVID-19 at home. Patient was sent to the ED and admitted to the hospital.
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| 56 | 2021-01-07 | dizziness |
Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi...
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Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi at vax site. Taken to ED from vax site. Started on epi drip. Admitted to SHC.
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| 56 | 2021-01-07 | pain in extremity |
The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went t...
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The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went to ER high BP and got tested for Covid results negative. On that Saturday my BP was still high and left calf pain. Since I'm usually hypotensive I monitored my BP however it has continued to elevate.
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| 56 | 2021-01-07 | pain in extremity | swollen uvula, throat lymph edema, arm soreness. has history of anaphylaxis |
| 56 | 2021-01-07 | dizziness |
upon presentation for second dose, patient informed us that last time she was dizzy and we had her s...
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upon presentation for second dose, patient informed us that last time she was dizzy and we had her sit for 30 minutes . Upon further conversation she mentioned that she was dizzy when walking to her car the first time (12/17/2021) . She said the first time she felt dizzy walking to her car and vomited, then laid in her car for an hour before being able to drive home. Didn't eat much that night. Received second dose today 1/8/2021. She was feeling dizzy and nauseated less than 10 minutes from injection. at 11;05 a.m. blood pressure was 139/66; 11:15 a.m. 126/71 at approximately 11:35 a.m. 139/73. MOved her with wheelchair from vaccination room to patient room on a bed. Applied 92 per nasal canula. Physician in room (not privy to exam) Zofran 4mg Sublingual given and transported via wheel chair to other side side of hospital to ER
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| 56 | 2021-01-08 | pain |
Body Muscle pains through out the body it started on 12/20/2020 The muscles were swollen One day I ...
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Body Muscle pains through out the body it started on 12/20/2020 The muscles were swollen One day I had a slight fever I also had dehydration. Virtual appointment with my doctor
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| 56 | 2021-01-08 | pain |
Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded ...
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Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded to Tylenol but returned as Tylenol wore off.
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| 56 | 2021-01-08 | lethargy, pain | Fever, body aches, lethargy, headach |
| 56 | 2021-01-08 | dizziness, numbness |
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l...
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Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
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| 56 | 2021-01-08 | dizziness, pain |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-08 | pain | Next day felt extremely tired, chills, sore throat, headache, body ache |
| 56 | 2021-01-08 | vertigo | Severe vertigo, vomiting for 12 hours. Vertigo for 5 days. Out of work for 5 days. |
| 56 | 2021-01-08 | pain | temp 100 F , chills body aches mainly lower back ache |
| 56 | 2021-01-09 | migraine, pain, pain in extremity |
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ...
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1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
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| 56 | 2021-01-09 | feeling hot, pain, weakness |
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately...
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Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
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| 56 | 2021-01-09 | tingling, pain in extremity | Sore arm and tingling in fingers |
| 56 | 2021-01-10 | pain in extremity, feeling hot |
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel...
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01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
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| 56 | 2021-01-10 | pain in extremity |
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic...
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10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
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| 56 | 2021-01-10 | pain in extremity, pain |
3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, l...
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3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, less than flu shot pain. lasted 3 days. 6 hours post vaccine- bad headace-lasted 29 hours 8 hours post vaccine-mild chills. Lasted 5 minutes 10 hours post vaccine- another episode of chills-lasted 10 minutes 12 hours post vaccine-moderate tiredness. Lasted 24 hours 12 hours post vaccine-generalized achiness-lasted 24 hours
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| 56 | 2021-01-10 | pain in extremity |
After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to t...
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After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to the ER because I had a lot of pain on my legs mainly on my right one I thought I had a blood clot but in the ER they told me it was just a reaction the the vaccine.
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| 56 | 2021-01-10 | pain in extremity |
Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 a...
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Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 at 10 am. Took Advil with relief. Sunday afternoon low grade temperature of 99 at 3 pm. Reports arm soreness bilateral.
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| 56 | 2021-01-10 | pain | Fatigue 1/9/2021 day of injection Body ache and joint pain 1/11/2021 |
| 56 | 2021-01-10 | pain in extremity | Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion |
| 56 | 2021-01-10 | pain | Fever, chills, body aches, injection area red and warm to touch started the next day |
| 56 | 2021-01-10 | pain |
I had sore throat starting on 12-24-2020 with chills, muscle aches, flu like symptoms. Next day I ha...
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I had sore throat starting on 12-24-2020 with chills, muscle aches, flu like symptoms. Next day I had temperature of 99.7 and my whole body was aching. The following day I started taking Tylenol and rested and took another rapid test 12-24-2020 and rested so more. I went for another test on 12-27-2020 for a rapid test and on 12-30-2020 I was let know i was positive for Covid. I still has some cough today that comes and goes.
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| 56 | 2021-01-10 | bell's palsy | Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination |
| 56 | 2021-01-10 | pain | Pfizer Bio NTech COVID 19 vaccine EUA- symptoms began 01/06/21 chills, fever, HA, body aches, N&V |
| 56 | 2021-01-10 | weakness |
Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the P...
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Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.
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| 56 | 2021-01-10 | weakness |
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports...
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Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
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| 56 | 2021-01-10 | pain in extremity |
SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AN...
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SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AND FATIGUE STATED ON 1/9/2021, TOOK PERCOGESIC ALTERNATED WITH ACETAMINOPHEN
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| 56 | 2021-01-10 | pain in extremity |
STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBO...
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STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, FEVER, GENERALIZED JOINT PAIN, FATIGUE. TOOK PERCOGESIC AND ACETAMINOPHEN
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| 56 | 2021-01-10 | dizziness |
Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. A...
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Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. All lasting approximately 12 hours.
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| 56 | 2021-01-10 | pain, tremor, tenderness |
Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches a...
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Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches and fatigue on 12/10/21 local arm tenderness that started on 12/9/21
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| 56 | 2021-01-10 | dizziness |
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ...
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feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
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| 56 | 2021-01-10 | pain |
fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symp...
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fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symptoms began on 01/09 have continued through 01/11 but have gotten better.
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| 56 | 2021-01-11 | tingling, numbness, facial paralysis |
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ...
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Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
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| 56 | 2021-01-11 | tingling, dizziness, numbness |
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou...
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Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
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| 56 | 2021-01-11 | numbness, dizziness, tingling |
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit...
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Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
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| 56 | 2021-01-11 | dizziness, tingling, feeling hot |
I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha...
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I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
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| 56 | 2021-01-11 | dizziness |
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes...
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Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
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| 56 | 2021-01-11 | migraine |
Patient said they experienced a migraine after being vaccinated and also reported they are prone to ...
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Patient said they experienced a migraine after being vaccinated and also reported they are prone to migraines
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| 56 | 2021-01-11 | vertigo |
Receive first dose vaccine 12/18/20. On 12/24/20 awakened with vertigo/nausea/vomitting. Self treat...
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Receive first dose vaccine 12/18/20. On 12/24/20 awakened with vertigo/nausea/vomitting. Self treated (as had similar 4 years earlier) with Epley maneuver, rest. Symptoms gradually improved over 2 dayes. Received 2nd dose 1/8/21. Awakened early 1/12/21 with vertigo, nausea, vomitting. Again it is improving with self treatment but contacted UConn vaccine call center who suggested I file this.
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| 56 | 2021-01-11 | pain, pain in extremity | Shivers. Chills. Body aches , fever 101.2 tympanic Sore left arm |
| 56 | 2021-01-11 | pain in extremity | Sore Arm Can't lift arm |
| 56 | 2021-01-11 | pain in extremity | chills, elevated heart rate, headache, Sore Arm |
| 56 | 2021-01-11 | pain |
full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contac...
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full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 04Jan2021 14:45 at single dose for COVID-19 immunization at a workplace clinic. The patient's medical history was reported as none, no known allergies to medications, food, or other products and no other medical history. Concomitant medication in two weeks included progesterone, testosterone, colecalciferol (D3), calcium, "C", "E", and "Ty". No other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 04Jan2021 the patient received the injection. And on 05Jan2021, the patient experienced full day of full body aches, chills, headache, and miserable. No fever. The events started on 05Jan2021 05:00. On 06Jan2020, the patient felt great. No treatment was received for the events. The outcome of the events was recovered on 06Jan2021.
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| 56 | 2021-01-12 | dizziness |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | lethargy, lethargy, pain |
16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and p...
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16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and pains in joints, chills-cold hands,feet, lethargy, slight nausea, diarrhea. Symptoms subsided over the following 24 hours. Joint aches continue
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| 56 | 2021-01-12 | pain in extremity |
Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for...
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Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for several days and it went to my chest. I Medicated with: Mucinex and Advil sinus - but wasn't working. Telehealth call to DR. and He prescribed C-Pac - 250 mg - 5 day dose and decongestant: Guaifenesin 100 mg - 5 mg liquid - 10 ml every six hours by mouth as needed for 10 days and I took that decongestant for 6 days. Felt better at this point. Never had had this before.
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| 56 | 2021-01-12 | pain, feeling cold | Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days |
| 56 | 2021-01-12 | pain |
Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and...
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Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and sinus congestion.
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| 56 | 2021-01-12 | dizziness |
Felt lightheaded at work. Sent to ER had BP 183/101 hr 127, given IV fluids and discharged . Later t...
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Felt lightheaded at work. Sent to ER had BP 183/101 hr 127, given IV fluids and discharged . Later that evening had fever and chills.
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| 56 | 2021-01-12 | pain |
Fever; Chills; Fatigue; Body Aches; Headache; Nausea; Other vaccine same date; Other vaccine same da...
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Fever; Chills; Fatigue; Body Aches; Headache; Nausea; Other vaccine same date; Other vaccine same date; This is a spontaneous report from a contactable other health professional (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were none. On the 06Jan2021, other vaccine was vaccinated on the same date at left arm. On 07Jan2021 09:00, patient experienced fever, chills, fatigue, body aches, headache, nausea. Treatment of events "fever, chills, fatigue, body aches, headache, nausea" was unknown. Outcome of "Other vaccine same date" was unknown, while outcome of other events was recovering. Information on the lot/batch number has been requested.
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| 56 | 2021-01-12 | pain in extremity |
Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drai...
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Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drainage and pressure. Headache. Very congested. Medicated with Mucinex and Advil Sinus. A couple days later went to my chest. Got medical care from Telemed visit - Z-Pac - took for five days - 250 mg and a liquid decongestant: Guaifenesin - 100 mg/5 mm once every six hours for 10 days as needed. I took it for six or 7 days. Resolved.
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| 56 | 2021-01-12 | balance disorder, pain in extremity |
Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of adminis...
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Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of administration patient developed intermittent chills, fever 101.4 to 102.2 F , moderate to severe tension headache, mild muscle ache/joint pain, insomnia, severe fatigue, and mild nauseau. Fever lasted for approximately 48 hours. Other signs and symptoms resolved by 72 hours following vaccination. Patient also noticed mild fatigue as well as slight disorientation and slight loss of balance until 1/11/21. Patient was normal by 1/12/21. No specific treatments administered.
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| 56 | 2021-01-12 | lethargy |
Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up v...
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Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up very lethargic ; as day went on had severe fatigue. About six pm strike fever; headache and fatigue (fatigue was the worst). Muscle aches started on the 10th and through the 11th. Next day (11th) no more fever; still fatigue but not as bad (moderate). By 11th in evening was feeling better that night. But still did not feeling well at all. On 12th - joint pain on 12th; and swelling and redness and it had heat and some pain on injection site (maybe had before but I didn't notice before). Took advil through all of this. Still have a mild headache off and on and today as well. And feeling fatigue now, too. No longer taking Advil.
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| 56 | 2021-01-12 | pain |
significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours lat...
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significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours later fatigued in general not well-being, chills, fatigue, injection site pain, malaise new or worsened join and muscle pain
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| 56 | 2021-01-13 | dizziness |
"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began t...
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"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water. The dizziness lasted for 2 hours. Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior. This continued throughout the day. After being observed by staff, after 30 minutes I was given Benadryl tablet25 mg by mouth. The adverse event has also been reported to my manager and employee health.
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| 56 | 2021-01-13 | dizziness, weakness, tingling |
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine....
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56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
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| 56 | 2021-01-13 | pain |
ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, m...
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ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; headache; Minimal pain at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) intramuscular (left arm) on 07Jan2021 at 15:30, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) intramuscular (left arm) on 17Dec2020 at 15:15 for COVID-19 immunization. The patient previously received bactroban ointment and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 5:00 a.m. the patient's entire body hurts, including joints and muscles and also had severe headache and minimal pain injection site (less sore than first shot). Patient confirmed that she did not have any of these symptoms with the first dose. Patient took ibuprofen but did not seem to help. Patient is a registered nurse working in a small, rural hospital. Outcome of the events headache and minimal pain at injection site was unknown, while for the remaining events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 56 | 2021-01-13 | pain in extremity, pain |
Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed ...
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Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed 30 hours after vaccine). Temp 100.1, (approx 32 hours after vaccine). All resolved 43 hours after vaccine.
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| 56 | 2021-01-13 | dizziness |
Fever 103 Tylenol able to control fevers. Dizziness when standing headache and cough. Fever lasted ...
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Fever 103 Tylenol able to control fevers. Dizziness when standing headache and cough. Fever lasted 48 hours, Dizziness and cough lasted 1 day longer
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| 56 | 2021-01-13 | pain, pain in extremity |
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ...
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Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
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| 56 | 2021-01-13 | tremor |
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ...
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The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
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| 56 | 2021-01-13 | weakness |
approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to fee...
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approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to feel weaker and getting confused. C/O legs weighing 500 pounds and leg weakness with difficulty walking. Intermittent chills.
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| 56 | 2021-01-13 | pain in extremity |
itching/itching at the site and on her chest going all the way to her groin; rashes/She does have th...
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itching/itching at the site and on her chest going all the way to her groin; rashes/She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin; itching at the site; soreness on her arm; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), by injection via an unspecified route of administration on Arm Left on 06Jan2021 12:00 noon at single dose for covid-19 immunisation (front line health care worker). Medical history included Hot flashes, Hashimoto's disease, Osteoporosis and Allergy. Concomitant medications included ongoing estrogens conjugated/medroxyprogesterone acetate (PREMPRO) at 0.45mg; take once daily by mouth for Hot flashes from 2017, ongoing Levothyroxine at 50mcg; take once daily by mouth for Hashimoto's disease from 2014, ongoing alendronate sodium (FOSAMAX) at 70mg; take once weekly by mouth for Osteoporosis from 2017, montelukast sodium (SINGULAIR) at 10mg; take once daily by mouth for allergy from 2018, ongoing Azelastine at one spray per nostril daily for Allergy from 2019, ongoing Fluticasone at 50mg; one spray each nostril daily for Allergy from 2019, ongoing Hydroxyzine at 10mg; once daily by mouth for Allergy from 2019. The patient had the COVID-19 vaccine yesterday (06Jan2021) and today (07Jan2021) 16:00 experienced itching and rashes. She also had soreness on her arm. She is concerned whether this is expected of the COVID-19 vaccine and will it happen again because she has heard that the side effects may worsen on the second dose of the vaccine. What would happen if I don't get the second dose of the vaccine? Itching was reported as worsened. Rash was reported as worsened. Occupational Therapist calling regarding the Pfizer COVID 19 vaccine. States she had the vaccine yesterday and just started itching and can't get up with her primary care provider. Asking if this is a normal side effect? Will it happen again? Reports she received the first dose of the COIVID 19 vaccine 06Jan2021 at 12:00 noon in the left arm. Today 07Jan2021 within the last the hour, 16:00, she started itching at the site and on her chest going all the way to her groin. Adds she has a lot of allergies and that is how it always starts. She knows she will wake up with a red bathing suit rash. She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin. Reporter is Occupational Therapist reporting on herself She is unsure if she will take the second dose of the vaccine. Vaccination Facility Type was nursing home. No vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Physician Office or ER.Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The outcome of the events Itching and rash was not recovered. The outcome of the other events was unknown.
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| 56 | 2021-01-13 | pain in extremity, pain, dizziness |
left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; ...
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left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 07Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, allergic to certain types of chocolates. Concomitant medication included Levothyroxine and vitamins. The patient was also allergic to Quinine, tramadol, Dilaudid, Msg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left arm/shoulder soreness, headache, light headedness, fatigue and aches on 07Jan2021 11:45 AM. The patient received Tylenol and bed rest as treatment. Events outcome was not recovered. Information about lot/batch number has been requested.
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| 56 | 2021-01-13 | vertigo, dizziness |
patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15...
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patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15 minutes and having a glass of water she felt better
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| 56 | 2021-01-14 | pain |
"Felt great until 36 hours after shot. It just hit suddenly, felt exhausted, chills and body aches. ...
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"Felt great until 36 hours after shot. It just hit suddenly, felt exhausted, chills and body aches. Very bad from midnight to 230am. Got up a 6am with a very bad headache, at 9am I took tylenol. I got up at noon and felt great until midnight that night, same symptoms but much less severe. had fever/chills, no body aches. when i got up at 7am i had a headache but not as bad as previous."
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| 56 | 2021-01-14 | pain in extremity | Fever chills fatigue arm pain upset stomach bradycardia |
| 56 | 2021-01-14 | bell's palsy, tremor, tingling, facial paralysis |
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left...
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Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare. Jen Silvey spoke with patient on 1/6/2021 @ 2051: "Her face - no droop to left side of her face and lips- back to normal. But her tongue is still tingling."
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| 56 | 2021-01-14 | pain in extremity, one side paralysis, numbness |
Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment. Sharp pain down leg, w...
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Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment. Sharp pain down leg, with an achiness in bones of entire leg, numbness in toes at times, with increasing weakness. Received Doppler scan, X-rays, and MRI with no know problems seen. Required treatment of prednisone, anti-inflammatory meds, Percocet, gabapentin, as well as epidural.
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| 56 | 2021-01-14 | tremor | Mental confusion,shakes, foggy brain , things did not make sense to me, driving confusion |
| 56 | 2021-01-14 | dizziness |
She reports symptoms of dizziness. Patient rates her dizziness at 1 (1-10 scale), her dizziness does...
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She reports symptoms of dizziness. Patient rates her dizziness at 1 (1-10 scale), her dizziness does not change with position or activity. She reports "I only have a little dizziness, nothing else". She reports she her contacts are in place and her vision is unchanged. She questioned if this was in her head because someone she knows had dizziness after her COVID vaccine". Speech and behavior normal. ? Injection time 0814 Observation time 0814-0853 ? Treatment/intervention - Patient stayed in observation area >30 minutes, drank 480 ml of water while resting. Patient denied need for further evaluation. Husband is driving her home (this was pre-planned prior to injection).
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| 56 | 2021-01-14 | vertigo |
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration from 19Dec2020 11:00 AM at single dose on left arm for COVID-19 immunization. Age at vaccination was reported as 56 years. Patient was not pregnant at the time of vaccination. Medical history included cancer and penicillin allergies. Concomitant medications (received within 2 weeks of vaccination) included Irbesartan, Pantoprazole, Levothyroxine and Calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. COVID-19 vaccine was administered in the hospital. On 26Dec2020 13:00 (reported as 01:00 PM), patient experienced vertigo, then dizzy-lighted since. Patient also experienced loud hissing sounds in her ears. Patient's arm (site of injection) became sore again, numb to the touch and she felt like she had a sunburn when her clothes touch the skin. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for "vertigo-dizziness". The events were assessed as non-serious. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
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| 56 | 2021-01-14 | dizziness | dizziness, headache, nausea, "puffy thoat", BP 123/59, O2 sat 100%, HR 70 |
| 56 | 2021-01-15 | vertigo, dizziness |
vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizzines...
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vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizziness); a heightened sense of taste, sensitivity to light, and increased startle reaction to sudden sounds
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| 56 | 2021-01-16 | pain in extremity, dizziness |
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead...
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I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
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| 56 | 2021-01-17 | dizziness, weakness |
Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reporte...
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Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reported for herself, a 56-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Dec2020 at a single dose with lot number: EJ1685, and the second dose via an unspecified route of administration on 10Jan2021 at a single dose with lot number: EL3248, for COVID-19 immunization. The patient had no medical history nor concomitant medications. When patient had the first vaccine on 20Dec2020, she experienced dizziness, weakness and tiredness which lasted for 4 days. The outcome of the events was recovered with sequelae, patient received the second dose of the Covid-19 vaccine on 10Jan2021, she was also having dizziness, weakness and tiredness which were ongoing at the time of report.
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| 56 | 2021-01-17 | dizziness, weakness, lightheadedness, unresponsive to stimuli |
Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the ob...
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Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
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| 56 | 2021-01-18 | feeling of body temperature change, dizziness, weakness, vertigo |
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side ...
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Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 56 | 2021-01-19 | weakness |
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus...
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At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
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| 56 | 2021-01-19 | pain in extremity, dizziness |
From the evening of the day I have received the vaccination, my left arm started to feel dull contin...
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From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
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| 56 | 2021-01-19 | tingling |
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ...
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Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
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| 56 | 2021-01-19 | pain |
I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time ...
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I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time I arrived to work, my temperature was greater than 101 degrees Fahrenheit and I was told to go home. By the time I arrived home (40 minutes later), extreme chills and body aches. I have never experienced anything like it. The fever, chills, and body aches persisted throughout the day despite Tylenol. Fever broke around 2AM on 12.24.20, slept and felt perfectly fine later that morning.
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| 56 | 2021-01-19 | tingling | PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE |
| 56 | 2021-01-19 | facial paralysis, numbness |
Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was a...
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Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was admitted. She was afebrile; neurologic exam was consistent with a peripheral facial palsy on the right.
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| 56 | 2021-01-19 | pain, dizziness |
Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that s...
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Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that she woke up from a nap around 1500 hours with constant, midsternal chest pain. Chest pain is non-exertional, non-pleuritic, and non-radiating. She states chest pain is exacerbated by certain movements. Patient endorses lightheadedness.
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| 56 | 2021-01-19 | tingling | Patient reports tingling in hands, nausea, and sweating with the first dose. |
| 56 | 2021-01-19 | dizziness, numbness |
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination....
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Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination. Patient said she felt like she couldn't breathe. Taken to ED for further evaluation.
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| 56 | 2021-01-19 | pain in extremity, tremor |
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7...
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acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
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| 56 | 2021-01-19 | tingling | had itching and tingling the next day. with in 2 days hives all over chest and arms. |
| 56 | 2021-01-19 | pain in extremity | sore arm, gastric upset, tirednessn/a |
| 56 | 2021-01-21 | tremor | Chills, couldn?t get warm! Whole body couldn?t stop shaking, Pounding headache, Fever, & Vomiting. |
| 56 | 2021-01-21 | dizziness | Flushing, dizziness, throat tightening, difficulty swallowing |
| 56 | 2021-01-21 | pain | HA, BODY ACHES, JOINT PAIN |
| 56 | 2021-01-21 | pain |
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ea...
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Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
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| 56 | 2021-01-21 | numbness | Systemic: numb from the neck up |
| 56 | 2021-01-24 | dizziness |
2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started f...
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2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started feeling lightheaded 3 hrs post vaccine. Able to stay at work until 4pm, went home, felt lightheaded, ate a meal and felt somewhat better. Got up around 9:30pm, was on feet for a couple of minutes, went to kitchen and reached for a plate on top of the refrigerator. Had presyncopal aura, then fainted. Apparently fell on buttocks, which are sore. No other symptoms. Constitutional symptoms have resolved. Evaluated in ED today.
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| 56 | 2021-01-24 | pain |
chills, body aches, fever with a tmax of 101.3 started the next day. Treatment none, resolved by da...
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chills, body aches, fever with a tmax of 101.3 started the next day. Treatment none, resolved by day 3. Aleve was taken after symptoms resolved. Outcome: Complete resolution of symptoms, did not interfere with ADL's.
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| 56 | 2021-01-24 | dizziness, tingling, pain in extremity, tremor, tenderness |
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;...
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significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
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| 56 | 2021-01-25 | swollen extremities | Chills 1/23 Swollen lymph nodes in axillary of arm vaccine was administered |
| 56 | 2021-01-25 | pain, dizziness |
Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contact...
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Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BEL-3246), intramuscular in left arm on 10Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included allergies to blue dye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Versed, Parafon Forte and experienced allergies. On 10Jan2021 11:30 AM, the patient experienced dizziness, nausea, headache almost immediately followed by abdominal pain and body aches within 6 hours. No treatment given for the events. The patient recovered from the events on unspecified date. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.
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| 56 | 2021-01-25 | pain |
Fever on evening of second vaccine - highest was 100 - Fever between 98-99.6; Body aches throughout ...
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Fever on evening of second vaccine - highest was 100 - Fever between 98-99.6; Body aches throughout body Headache; Body aches throughout body Headache; Chills; This is a spontaneous report from a contactable Other HCP. This 56-year-old female Other HCP (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EL3246), via intramuscular at left arm on 12Jan2021 09:30AM at single dose for COVID-19 immunization. Medical history included known allergies: penicillin. Concomitant drugs included ascorbic acid (VITAMIN C). Historical vaccine included the first dose of BNT162B2 (Lot number: EH9899) on 22Dec2020 10:30AM via intramuscular at left arm for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 12Jan2021 08:00pm, patient had fever on evening of second vaccine -highest was 100 -Fever between 98-99.6 next day and evening, body aches throughout body, headache, chills, fever gone after 40 hours or so. No treatment for AE. Outcome of events was recovered in Jan2021.
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| 56 | 2021-01-25 | pain in extremity, pain |
Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all o...
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Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported. Information about lot/batch number has been requested.
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| 56 | 2021-01-25 | pain |
The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted ...
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The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted 4 3-4 days. I did seek medical attention at the emergency room day 3 and was hospitalized 1 day. I was found to have unexplained and unregulated hypoglycemia. The second shot I had body aches, headache, fever. I was able to manage my symptoms with Tylenol and Advil.
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| 56 | 2021-01-25 | dizziness |
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ...
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little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
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| 56 | 2021-01-26 | pain | Aches, nausea vomiting and Fever |
| 56 | 2021-01-26 | dizziness |
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ...
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headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-27 | migraine |
On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw ...
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On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.
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| 56 | 2021-01-27 | lethargy |
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point ...
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On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
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| 56 | 2021-01-28 | tingling |
CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any di...
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CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any difficulty breathing or any rashes/hives. Pt felt better after 30 mins and was cleared to RTW.
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| 56 | 2021-01-28 | unresponsive to stimuli |
She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagge...
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She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagged. NOT hypotensive. HYPERCARBIC. Difficult intubation. Transferred to our facility on VENT with bilateral pulmonary infiltrates, wheezy with size 6 ETT from outside facility.
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| 56 | 2021-01-28 | feeling hot, dizziness, tingling |
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ...
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close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-28 | dizziness |
experienced numbness on right arm (vaccinated arm) to fingers; dizziness; This is a spontaneous repo...
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experienced numbness on right arm (vaccinated arm) to fingers; dizziness; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on arm right from 14Jan2021 08:30 to 14Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Jan2021 08:35, 5 minutes after receiving vaccine experienced dizziness which lasted several hours, 10 minutes after receiving experienced numbness on right arm (vaccinated arm) to fingers which lasted into evening. The patient was given Benadryl by mouth, 25 mg. Tablet by nursing staff. The patient was not pregnant at the time of the report. Outcome of the events recovered with sequelae.
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| 56 | 2021-02-01 | unresponsive to stimuli | Employee was found unresponsive in floor at her home. EMS arrived and person had expired. |
| 56 | 2021-02-01 | lethargy |
Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spo...
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Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none. Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time. She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time
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| 56 | 2021-02-01 | feeling hot, weakness |
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se...
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sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-02 | pain, inability to speak, weakness, movement disorder |
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck througho...
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syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-05 | difficulty speaking |
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her secon...
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56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
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| 56 | 2021-02-20 | lethargy |
Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea,...
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Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea, vomiting
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| 56 | 2021-02-21 | dizziness |
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o...
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After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
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| 56 | 2021-02-21 | dizziness | I have been dizzy and my head feels cloudy and I can't stand up well without falling over. |
| 56 | 2021-02-21 | dizziness, tremor |
Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was cal...
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Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.
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| 56 | 2021-02-21 | dizziness |
Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation stati...
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Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation station in mall area of hospital for 15 minute observation, by another nurse.. At approx. 10:32, when observing nurse questioned pt about any headache, nausea, vomiting or other reactions, , pt c/o headache, then dizziness, nausea and ultimately started attempting to vomit, having "dry heaves" only. This nurse calls Code RRT to location of event.. Pt was taken to ER via stretcher.
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| 56 | 2021-02-21 | pain in extremity, weakness |
Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness ...
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Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness to her left arm followed by general myalgias to her body and weakness. She states she sx have not resolved and has only been taking ASA. Rx Voltaren gel and Tizanidine refill given.
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| 56 | 2021-02-22 | tingling |
Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, includ...
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Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, including during the night but it comes and goes. Both hands have the tingling finger tips.
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| 56 | 2021-02-23 | pain |
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala...
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sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-25 | facial paralysis, one side paralysis, inability to speak |
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport ...
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15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours
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| 56 | 2021-02-25 | dizziness |
burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness...
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burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration on 11Feb2021 09:00 at single dose in left arm for COVID-19 immunisation. She received the first dose BNT162B2 (lot number: EL8982) in Left arm on 22Jan2021 06:00 PM for COVID-19 immunisation. Medical history included depression, high blood pressure, thyroid disorder, obesity. The patient was allergic to codeine and pennicilian. The patient was not pregnant at the time of vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC), lisinopril, levothyroxine, bupropion hydrochloride (WELLBUTRIN), omeprazole (OMEP). The patient previously took the first dose of Shingrix (lot number: 5816001912) 50 mcg on Dec2020 in left arm for immunisation. On 12Feb2021 09:00, 24 hrs post 2nd vaccine BNT162B2, the patient experienced extreme fatigue, muscle pain, dizziness and 36 hrs after the second vaccine (12Feb2021 21:00) she also started having burning pain in her left armpit, and the next morning also burning pain in both armpits. No treatment received for the adverse event. Events outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 56 | 2021-02-28 | dizziness, pain |
Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; f...
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Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 56 | 2021-02-28 | dizziness, feeling hot |
almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very ...
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almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.
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| 56 | 2021-02-28 | pain in extremity |
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing mo...
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legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
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| 56 | 2021-03-03 | bell's palsy, dizziness |
Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one...
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Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.
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| 56 | 2021-03-03 | numbness |
swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbnes...
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swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
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| 56 | 2021-03-06 | feeling hot |
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa...
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Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
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| 56 | 2021-03-09 | vertigo, vertigo |
Room spinning unable to stand up; when attempting to stand vomitting uncontrollably; lasted 2-days; ...
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Room spinning unable to stand up; when attempting to stand vomitting uncontrollably; lasted 2-days; unable to walk or stand; crawled to make it to the bathroom; - Started Saturday evening, February 6 - Monday, February 8 when I went to urgent care
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| 56 | 2021-03-13 | pain in extremity |
Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. W...
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Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. Was hospitalized from 2/28 until 3/5. Left hospital with no diagnosis and no real relief
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| 56 | 2021-03-14 | pain, unresponsive to stimuli |
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre...
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annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
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| 57 | 2021-01-01 | pain | Fever 101.2, body aches, joint pain, nausea |
| 57 | 2021-01-01 | weakness, pain |
On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all n...
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On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all night long. I had severe body aches and chills. I was unable to find my thermometer so am not sure of tempertature. I had lower back pain so severe I couldn't lie down. I tried to take Tylenol but was unable to keep it down. By morning I got access to Tylenol suppositories, Dramamine, and a thermometer. My temperature before Tylenol was 104.4. These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids. I received a negative COVID test on Thursday. I have only been this ill once before in my life. By Thursday I was not longer febrile, only weak and exhausted. I have to now determine whether or not to get the second vaccination. I know this seems to be a somewhat delayed reaction. Any advice would be appreciated.
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| 57 | 2021-01-01 | weakness, pain in extremity, dizziness, pain |
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired....
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Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
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| 57 | 2021-01-02 | weakness |
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ...
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Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
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| 57 | 2021-01-03 | numbness, feeling of body temperature change, tremor |
10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experienc...
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10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days
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| 57 | 2021-01-03 | pain |
7-8 hours after the vaccine on (12/30/20) I started feeling tired and sluggish. Next day (12/31/20) ...
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7-8 hours after the vaccine on (12/30/20) I started feeling tired and sluggish. Next day (12/31/20) at 9:30 am I started with body aches, chills and headache. I got a fever of 100.2 at 4:00 pm. I took 800mg of Ibuprofen at 4:00 pm and 9:30 pm and fever broke at 12:00 am. Next day (1/1/21) I still had a tiny headache and felt very tired. I didn't start feeling better until Saturday (1/2/21). On Sunday (1/3/21) I felt better and was able to go outside for some fresh air.
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| 57 | 2021-01-03 | numbness | Numbs hands and feet, elevated blood pressure and tachycardia. |
| 57 | 2021-01-03 | feeling hot, dizziness, tremor |
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach...
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right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
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| 57 | 2021-01-04 | weakness, dizziness |
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio...
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01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
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| 57 | 2021-01-04 | pain |
24 hours after vaccine I started feeling body aches, fever of 102.2 and chills. I went to bed and n...
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24 hours after vaccine I started feeling body aches, fever of 102.2 and chills. I went to bed and next day I had a sore throat, joint pain, body aches and slept all day. Fever lasted 18 hour (went down to 99.8 by morning). Symptoms lasted 36 hours. Was fine after that.
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| 57 | 2021-01-04 | lethargy, migraine |
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1...
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48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
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| 57 | 2021-01-04 | pain, pain in extremity | DEVELOPED SORENESS IN ARM, EXTREME FATIGUE, AND BODY ACHES. |
| 57 | 2021-01-04 | dizziness | Dizziness, Chills and Pale |
| 57 | 2021-01-04 | tingling |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-04 | dizziness |
Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes...
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Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes. Then the patient felt dizzy and her BP was elevated (SBP ~135 mmHg) than her normal which is around 90/60 mmHg.
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| 57 | 2021-01-04 | dizziness |
Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure a...
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Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine. Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more IV fluids. Slow recovery and observed over 5 hours. Went home.
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| 57 | 2021-01-04 | dizziness |
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel...
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Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
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| 57 | 2021-01-04 | dizziness |
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs...
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metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 57 | 2021-01-05 | tingling |
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov...
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Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
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| 57 | 2021-01-05 | dizziness | Dizziness |
| 57 | 2021-01-05 | dizziness |
Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at les...
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Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE). The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
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| 57 | 2021-01-05 | pain | Fever, muscle aches, body aches, headache |
| 57 | 2021-01-05 | dizziness, numbness, pain in extremity, tingling |
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey...
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Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
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| 57 | 2021-01-05 | pain in extremity, dizziness, tremor |
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h...
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Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
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| 57 | 2021-01-05 | difficulty speaking, weakness, dizziness, tremor |
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn...
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Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
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| 57 | 2021-01-05 | dizziness |
got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactabl...
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got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactable consumer nurse assistant (patient). A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EH9899) at single dose on 28Dec2020 for covid-19 immunisation, administered at the hospital she worked at. Medical history included cholesterol. The patient reported taking unspecified concomitant medications. The patient got lightness in my head, had been dizzy and experienced headache in Dec2020. No treatment received. The outcome of events was unknown.
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| 57 | 2021-01-05 | difficulty speaking |
post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporti...
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post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.
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| 57 | 2021-01-06 | pain | CHILLS, FEVER, BODY AND HEAD ACHES |
| 57 | 2021-01-06 | pain | Chills, body aches, fever, headache |
| 57 | 2021-01-06 | pain |
I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever w...
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I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.
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| 57 | 2021-01-06 | pain in extremity |
Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours af...
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Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours after receiving vaccine. Both these symptoms continued until medical evaluation on 07 Jan.
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| 57 | 2021-01-06 | pain, tremor, dizziness |
ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZ...
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ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZY AND LIGHTHEADED THAT LASTED FOR 3 DAYS. SINCE THEN I HAVE A BAD HEADACHE, FEELING NAUSEA AND VERY LIGHT HEADED AT TIMES.
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| 57 | 2021-01-06 | pain in extremity, migraine, pain |
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early a...
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On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.
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| 57 | 2021-01-06 | pain, weakness | Patient reported pain and weakness |
| 57 | 2021-01-06 | dizziness |
Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on...
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Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on 01/06/21 reports extreme fatigue and continued sore arm at injection site. 1000 started having chills and generalized muscle aches. Temperature elevated to 101.2 at 1545, took Tylenol and temp went down to normal range with 1-2 hours back to 100.0 at 1815. Reports dizziness during that time as well.
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| 57 | 2021-01-06 | pain in extremity |
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in...
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Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-06 | feeling hot |
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI...
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WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
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| 57 | 2021-01-06 | dizziness |
at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on ar...
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at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on arms. pt was evaluated by EMS. BP 124/80, P 82, O2 Sat 100%. pt reports feeling better and declined EMS transport to hospital and left AMA 4:26
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| 57 | 2021-01-06 | tingling, dizziness |
pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt s...
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pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.
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| 57 | 2021-01-07 | dizziness |
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: R...
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Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: Recommended that she seek emergent care
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| 57 | 2021-01-07 | dizziness | Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative: |
| 57 | 2021-01-07 | pain |
Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol...
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Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol, benadryl Next day at time of report, symptoms had not resolved.
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| 57 | 2021-01-07 | pain |
Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection ...
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Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-07 | dizziness |
Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient h...
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Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unknown route, on 30Dec2020 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included hypothyroidism, osteoporosis and COVID-19 (prior to vaccination). No known allergies. Relevant concomitant medications included levothyroxine and alendronate sodium (FOSAMAX). The patient was vaccinated at Workplace Clinic, age at vaccination was 57-year-old. No other vaccine was received in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient developed nausea 20 minutes after vaccine (on 30Dec2020, at 09:05), then headache, dizzy, fever started about 2 hours after (on 30Dec2020, at 10:45). The patient was not treated for the events. The outcome from the events was unknown.
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| 57 | 2021-01-07 | pain | Pt report body aches, headache and fever of 101.5. Treated with Tylenol with mild improvement |
| 57 | 2021-01-07 | tingling |
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ...
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Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
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| 57 | 2021-01-07 | pain in extremity |
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym...
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Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
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| 57 | 2021-01-07 | pain in extremity | arm more sore than first shot; diarrhea- mild |
| 57 | 2021-01-07 | numbness, weakness, pain in extremity, tingling |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-08 | numbness, bell's palsy |
2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all...
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2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.
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| 57 | 2021-01-08 | pain in extremity | Fever Sore arm around 12 noon; chills 10pm for an hour, then fever 101-3F; relieved with tylenol |
| 57 | 2021-01-08 | pain, weakness |
Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick ...
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Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick nasal/sinus mucus.
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| 57 | 2021-01-08 | balance disorder, vertigo |
I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, ...
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I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, fever up to 100, severe fatigue, went home after work and slept til the next morning, went to work, took ibuprofen, and the myalgias improved and felt better. But around 3 pm, Jan 6, I got mild vertigo. By about 7pm Jan 6, I noticed my L ear didn't hear well. I changed the battery in my hearing aide and cleaned it but It made no difference. I woke up on Jan 7 with severe vertigo and hearing loss. I did Epley's maneuvers with no effect. I have had similar episodes. I went to work, but gave up when I could not hear patients talking to me. I went to the Emergency Dept and got admitted. I was too unsteady on my feet. Audiogram showed profound hearing loss both ears and almost complete loss of discrmination in R ear. I was put on high dose steroids. Also having tinnitus (mostly whooshing sound of my own pulse). MRI negative. Blood work negative. Some mild improvement now, after 1 dose steroids.
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| 57 | 2021-01-09 | tingling |
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr...
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Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
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| 57 | 2021-01-09 | pain in extremity |
Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/202...
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Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/2021
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| 57 | 2021-01-09 | migraine | Severe Migraine |
| 57 | 2021-01-10 | tremor, pain |
Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shakin...
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Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shaking. Was so cold, had to get a heating blanket to put over me, along with 2 blankets. Was shaking so bad, could hardly walk. Was slightly disoriented at the time. This lasted for 4 hours. Temperature is normally 95.6, did rise to 98.7. Had severe body aches that lasted until the next day, but were not as severe. the following day was very tired and muscles were achy. I did take tylenol, which seemed to help.
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| 57 | 2021-01-10 | pain | Body Aches, headache, Swollen Lymph nodes |
| 57 | 2021-01-10 | pain, dizziness, lethargy | Dizziness, body ache, lethargic, lump at site of injection for about 5-7 days |
| 57 | 2021-01-10 | pain in extremity |
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C...
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HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
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| 57 | 2021-01-10 | speech disorder, difficulty speaking |
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled...
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Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-10 | dizziness | Lightheaded, dizzy. Vitals okay. Symptoms resolved. |
| 57 | 2021-01-10 | pain |
Low grade temp, chills, headache and body ache. Started early morning and were resolved within 12 h...
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Low grade temp, chills, headache and body ache. Started early morning and were resolved within 12 hours of onset
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| 57 | 2021-01-10 | tremor |
Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestio...
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Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestion, HA and CP. Friday evening shaking chills and fever with extreme fatigue. GI symptoms and congestion Saturday. Feeling better by Saturday evening.
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| 57 | 2021-01-10 | pain | Redness and pain Rash |
| 57 | 2021-01-10 | pain |
Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling ...
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Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling aching all over. Then the next day, I awoke with a warm area around injection site. Warm to touch, and is very tender.
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| 57 | 2021-01-10 | pain |
Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no bi...
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Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no big deal. I had some redness, then on the next day, Saturday I started having body aches everywhere, I took two tylenol, and then I was fine. Then when I awoke the next morning, my arm was really sore. The injection site is red and warm and is tender, but not bad bad. The warmth of it is the worst part.
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| 57 | 2021-01-10 | pain | Severe body aches, severe headache, elevated temperature (highest 100.3F) |
| 57 | 2021-01-10 | pain | Site Pain, HA, Fever, Joint pain, Body Aches |
| 57 | 2021-01-10 | pain | Sore throte, headache, body aches, wet couph, glands are swollen, and runny nose |
| 57 | 2021-01-10 | pain, pain in extremity |
Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if ma...
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Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if making a fist. Now pain when holding a mug or glass but not other movement. Still swollen at time of report 1/11/2021 but much less painful. On the 28th and 29th of December I took 200mg ibuprofen, 3 or 4 doses over the two days, with some benefit.
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| 57 | 2021-01-10 | feeling hot | c/o burning/ warmth to throat |
| 57 | 2021-01-10 | inability to speak |
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev...
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experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
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| 57 | 2021-01-10 | dizziness |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
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| 57 | 2021-01-10 | numbness | muscle aches chills fever right knee where quad is, is numb |
| 57 | 2021-01-10 | weakness, dizziness |
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ...
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nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
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| 57 | 2021-01-11 | dizziness, tingling |
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describ...
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At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
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| 57 | 2021-01-11 | pain | Fever, Headache, body aches, fatigued |
| 57 | 2021-01-11 | dizziness | Mylgias, light headed, headache |
| 57 | 2021-01-11 | pain |
Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID va...
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Patient had mild bilateral knee and hip pain 1 month ago, then she received her 1st dose of COVID vaccine on 12/14/20. Her joint pain worsened then on 1/4/21 she received her 2nd dose of COIVD vaccine on 1/4/21 and then her pain increased in spread up to her shoulders. She was seen at immediate care on 1/11/21 because her joint pain had worsened throughout and her shoulder pain was making it difficult to raise her arms above the level of her shoulders. Her pain was made worse w/ movement.
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| 57 | 2021-01-11 | dizziness, numbness, feeling hot |
dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare prof...
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dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 13:45 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took cortisol [cortisone acetate]. The patient felt hot and acutely numb and dizzy within first few moments on 06Jan2021 13:45. The outcome of the events was recovered 06Jan2021 13:45. No treatment received for the adverse events. The reporter assessed as the events as non-serious. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Batch/lot was not available/provided to reporter at the time of report completion. Information about lot/batch number has been requested.
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| 57 | 2021-01-11 | pain |
too sick; Fever; muscle aches; headache; body aches; This is a spontaneous report from a contactable...
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too sick; Fever; muscle aches; headache; body aches; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration left arm on 04Jan2021 19:30 (07:30 PM) at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included escitalopram oxalate (LEXAPRO) and ergocalciferol (VIT D). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered in a hospital. The patient experienced fever, muscle aches, headache and body aches on 05Jan2021 09:00 PM (21:00). The patient was too sick to get out of bed to find lot details. The patient did not received treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the event sickness was unknown while the outcome of the other events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-12 | pain |
10:30pm, fever began along with chills. Fever 101.6 degrees via thermometer. on 01/12/21 at 8am, bod...
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10:30pm, fever began along with chills. Fever 101.6 degrees via thermometer. on 01/12/21 at 8am, body aches and head ache occurred. Fever reduced but was consistent all day at 100.7 degrees. Tylenol was taken 01/12/21 at 1am and 8am. called the vaccine hotline via UConn Health at 9am and it was advised to stop Tylenol. on 01/13/21 at 1am. all symptoms were gone. temperature normal, no more body aches or chills.
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| 57 | 2021-01-12 | swollen extremities, dizziness |
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ...
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1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
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| 57 | 2021-01-12 | pain in extremity | Arm soreness headache |
| 57 | 2021-01-12 | numbness, tingling |
C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, B...
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C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, BP: 147/82; T: 98.1 DEG. F. 1050: LEFT FACILITY, NO COMPLAINTS.
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| 57 | 2021-01-12 | pain in extremity, pain | Chills, fever, headache, body aches, upset stomach, pain in arm of vaccine |
| 57 | 2021-01-12 | dizziness, pain in extremity, pain |
Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ac...
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Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ache and shaking chills. Improved with Tylenol. Today still achy but I've continued the Tylenol.
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| 57 | 2021-01-12 | pain, pain in extremity |
Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire b...
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Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire body lasting 3 days
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| 57 | 2021-01-12 | dizziness |
immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs ...
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immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs after
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| 57 | 2021-01-12 | pain in extremity, pain | severe pain in right arm, and diffuse body aches, headache |
| 57 | 2021-01-12 | tremor | severe tremors,tachycardia |
| 57 | 2021-01-13 | pain |
Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; Th...
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Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 57 | 2021-01-13 | migraine, pain |
Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, ...
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Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, fatigued, body aches, nausea, pain throughout whole body.
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| 57 | 2021-01-13 | pain |
Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms start...
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Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms started 10 hours after receiving the vaccination.
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| 57 | 2021-01-13 | pain, weakness |
Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous r...
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Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-13 | feeling cold |
Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today ...
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Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today 1/13/21 still a little fatigue. at work today. COVID negative 1/11/21 negative, getting tested every week. denies COVID exposure.
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| 57 | 2021-01-13 | dizziness | Headache, chills, fever, dizziness, sweating |
| 57 | 2021-01-13 | pain, weakness |
I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and...
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I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted (12/25/20) one day - discharged on 12/26/20 at night
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| 57 | 2021-01-13 | pain |
Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nau...
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Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
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| 57 | 2021-01-13 | difficulty speaking |
Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min,...
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Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min, pt reports sore, pruritic throat, hoarse voice, difficulty breathing. Pt administered her own EpiPen and received a nebulizer treatment before transfer to ED. At ED, minimal residual symptoms but received prednisone and prn diphenhydramine.
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| 57 | 2021-01-13 | pain in extremity |
exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay ...
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exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
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| 57 | 2021-01-13 | weakness |
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa...
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throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
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| 57 | 2021-01-13 | numbness, tingling | tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min. |
| 57 | 2021-01-13 | tingling, dizziness |
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g...
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tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
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| 57 | 2021-01-14 | tingling |
20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth...
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20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth, feeling of thick tongue, tingling from the neck to the top of her head. Took 25 mg Benadryl while in her car. No swelling and no respiratory distress. After 30 minutes, she didn't feel worse so she drove home (50 minute drive). Her symptoms resolved around 9pm (about 1 hour, 20 minutes after taking Benadryl).
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| 57 | 2021-01-14 | pain in extremity |
After receiving the first vaccine, my arm hurt all the way to my wrist and became weak. Lasted almos...
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After receiving the first vaccine, my arm hurt all the way to my wrist and became weak. Lasted almost till I got my second vaccine. The second vaccine is causing the same thing. My muscles in my upper arm hurt really bad, the pain goes down to my wrist and my arm is weak. Its been 4 days since the second vaccine and its not stopped at all.
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| 57 | 2021-01-14 | pain in extremity, pain, dizziness |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-14 | bell's palsy | Bell's Palsy |
| 57 | 2021-01-14 | pain |
Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site sore...
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Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site soreness) Symptoms resolved by the next day with ibuprofen.
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| 57 | 2021-01-14 | dizziness, pain, pain in extremity | Dizziness, Body ache Teary eyes pain to right arm Headache |
| 57 | 2021-01-14 | dizziness |
Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramp...
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Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramping and Headaches continued intermittently. I took Excedrin as needed for symptoms. Itchiness started after a week and rash developed on 1/14/2021. I am waiting for return call from my Primary Doctor. I started taking Benadryl 25mg for rash/itchiness as needed.
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| 57 | 2021-01-14 | pain in extremity | Sore arm |
| 57 | 2021-01-14 | dizziness |
difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness...
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difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation. Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection; 9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-14 | pain, numbness, tremor |
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac...
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low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
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| 57 | 2021-01-15 | pain |
Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain,...
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Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable. Able to drink, normal stool, no other symptoms
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| 57 | 2021-01-15 | dizziness | Debilitating dizziness and vision impairment |
| 57 | 2021-01-15 | weakness |
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled a...
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Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
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| 57 | 2021-01-15 | pain |
On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started havin...
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On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started having visual disturbances. The next morning 12/23/2020 I woke up with a bloody eye it was my right eye it lasted one day. On the following Monday on 12/28/2020 I was not feeling good I started getting headaches, feeling aching, at night I started getting fevers, congestion, & fatigue. It went away on 1/1/2020. Seen doctor on 12/29/2020
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| 57 | 2021-01-16 | pain in extremity |
Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficul...
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Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficulty walking , skin self like bad sunburn when touched. lasted approximately 36 hrs. For approx 12 more hrs moderate symptoms, then 24hrs minor symptoms. Started on Tuesday night resolved by Saturday morning.
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| 57 | 2021-01-16 | pain in extremity |
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0...
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I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
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| 57 | 2021-01-17 | pain | Body aches and joint pain |
| 57 | 2021-01-17 | pain, feeling cold |
Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took T...
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Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took Tylenol Xtra Strength.
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| 57 | 2021-01-19 | pain |
Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup...
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Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup neg. Was advised that chest pain may be muscular pain from vaccine. Chest pain resolved. Continues to have fatigue, headache.
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| 57 | 2021-01-19 | dizziness, weakness |
Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday...
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Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
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| 57 | 2021-01-19 | pain |
Developed fever and headache after receiving vaccine. 1st vaccine had fever after 72 hours, develope...
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Developed fever and headache after receiving vaccine. 1st vaccine had fever after 72 hours, developed cold symptoms and intestinal issues after 6 days. 2nd vaccine fever developed 26 hours after receiving, now 28 hours later having aches and headache and abdominal pain.
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| 57 | 2021-01-19 | lethargy | Fever, lethargy, pain in arm around injection site, headache |
| 57 | 2021-01-19 | pain | Headache Body aches Malaise |
| 57 | 2021-01-19 | dizziness, pain in extremity |
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w...
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I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
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| 57 | 2021-01-19 | tingling |
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f...
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Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
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| 57 | 2021-01-19 | pain |
Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report...
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Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 57-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685), via intramuscular at left arm, on 31Dec2020 12:30, at single dose for COVID-19 immunisation. Medical history included ongoing chronic fatigue syndrome, fibromyalgia, sun allergy and lactose intolerant (allergy). Concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient did not receive other vaccine in four weeks nor other medications in two weeks. The patient experienced temperature 99.3, nausea, headache, bodyaches, fatigue, left hip pain, all on 01Jan2021 15:45, no treatment was received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered in Jan2021.
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| 57 | 2021-01-21 | pain in extremity | Arm, Neck pain & severe nausea |
| 57 | 2021-01-21 | bell's palsy | Bell's palsy - left |
| 57 | 2021-01-21 | dizziness | Headache, dizziness and severe pain at injection site |
| 57 | 2021-01-21 | inability to speak |
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri...
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Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
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| 57 | 2021-01-21 | pain | Temps 101-102.5, headache, body aches, lasted 18-20h, treated w ibuprofen and rest |
| 57 | 2021-01-21 | pain | chills, headache, body aches, pain and swelling at the injection site |
| 57 | 2021-01-24 | pain |
Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea....
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Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea. Also headache.
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| 57 | 2021-01-24 | weakness |
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta...
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Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
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| 57 | 2021-01-24 | tenderness | Elevation of the lymph node in the left armpit with tenderness |
| 57 | 2021-01-24 | numbness, tingling | Immediately felt numbness and tingling in arm and fingers |
| 57 | 2021-01-24 | lethargy | Nausea, vomiting , cold sweats , throat warm, lethargic fatigue. |
| 57 | 2021-01-25 | numbness |
Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old f...
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Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular (left arm) on 23Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies (NKA). The patient had no COVID prior vaccination. The patient is not pregnant. Concomitant medications included unspecified medications administered in two weeks; no other vaccines received in four weeks. The patient experienced left leg numbness on 25Dec2020 at 16:00. Treatment done for the event included tests and procedures which included magnetic resonance imaging (MRI) and X-ray-both with unknown results on an unknown date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not tested post vaccination. The event was resolving. No follow up attempts are possible. No further information is expected.
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| 57 | 2021-01-25 | dizziness |
Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her hea...
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Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing. Patient was taken to the medic location. VS= 192/116, HR 152, O2 sat=99%
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| 57 | 2021-01-25 | dizziness, pain, weakness |
chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired fe...
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chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired feeling
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| 57 | 2021-01-25 | pain |
fever, chills and body aches - took Tylenol and drank a lot of fluids - fever gone today, small res...
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fever, chills and body aches - took Tylenol and drank a lot of fluids - fever gone today, small residual headache and small amt of body aches
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| 57 | 2021-01-26 | pain in extremity |
Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; pati...
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Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.
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| 57 | 2021-01-26 | pain |
Flu-like symptoms started immediatedly and continued after the expected days (1-2 days). The rest of...
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Flu-like symptoms started immediatedly and continued after the expected days (1-2 days). The rest of the week I experienced fever, body aches, shortness of breath and sweats. On Saturday 1/23/21 I took COVID19 test and the results were positive. I had no symptoms before the vaccine.
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| 57 | 2021-01-26 | pain |
Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post inje...
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Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post injection, pain and tenderness around injection area.
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| 57 | 2021-01-26 | numbness |
Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine an...
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Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine and pnc. she reports that her they cause HA and facial swelling. Pt received vaccine at 1405 and went to 30 min observation area. at 1420 this provider was contacted by the patient and she reported that feeling numbness and drooping to the right eye lid. The patient was then brought for eval by this provider and EMT. The patient continued her observation until 1510 and at that time she reported that she was back to normal and continued to be without HA.
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| 57 | 2021-01-26 | pain in extremity | Severe fatigue, radiating arm pain, chills and mild headache |
| 57 | 2021-01-26 | pain | all symptoms somewhat mild: headache, achiness, sore throat, malaise |
| 57 | 2021-01-27 | weakness, pain, migraine |
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde...
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generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
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| 57 | 2021-01-28 | pain | Chills, body ache, cough, severe fatigue; 12 hr duration; treated with Ibuprofen |
| 57 | 2021-01-28 | pain |
Headache and body ache started on 01/29/21 after the Second Covid-19 vaccine was administered on 01/...
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Headache and body ache started on 01/29/21 after the Second Covid-19 vaccine was administered on 01/28/21
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| 57 | 2021-01-28 | tenderness | Neck pain/tenderness, Shoulder tenderness moving to right side, lymphadenopathy |
| 57 | 2021-01-28 | pain, swollen extremities, numbness |
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar...
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fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-28 | migraine | headache like a migraine |
| 57 | 2021-01-28 | tingling, feeling hot |
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;...
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increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-31 | lethargy, weakness |
Patient states felt hot flashes following injection in waiting room went home became lethargic that ...
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Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe. Did not go to the ER. Patient states fully recover the next day and fully recovered 5 days later. No rashes fever generalized weakness that resolved.
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| 57 | 2021-01-31 | pain, pain in extremity |
Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am C...
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Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated "could be ELO or ERO"), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that "I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated "No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine." Nurse added, "I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call." She was referring to the 'TCP'. "When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do." The outcome of the event "I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID" was not recovered and of the remaining events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.
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| 57 | 2021-02-03 | weakness, numbness, pain, tingling |
Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over an...
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Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg. Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.
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| 57 | 2021-02-08 | tingling | Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911. |
| 57 | 2021-02-09 | pain |
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa...
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103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-10 | nerve pain |
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca...
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bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | weakness, tremor, dizziness |
dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness...
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dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism. Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects. She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects. Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | numbness, tingling |
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness...
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numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-10 | weakness, dizziness |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-14 | pain, pain in extremity |
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain...
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Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
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| 57 | 2021-02-14 | weakness, pain in extremity, pain |
diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feelin...
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diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,
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| 57 | 2021-02-17 | nerve pain, pain in extremity, tingling |
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ...
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R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-20 | dizziness |
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness...
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She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
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| 57 | 2021-02-21 | vertigo |
After getting my first covid vaccine on 1/13/21, I woke up the morning of 1/15/21 with vertigo, whic...
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After getting my first covid vaccine on 1/13/21, I woke up the morning of 1/15/21 with vertigo, which I had never experienced before. It lasted 3 to 4 hours before resolving on it's own. After getting my second covid vaccine on 2/3/21, I again experienced an episode of vertigo starting the morning of 2/14/21 lasting 3 to 4 hours, then again the morning of 2/15/21 lasting all day until the morning of 2/16/21 before resolving on it's own.
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| 57 | 2021-02-21 | pain in extremity |
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,...
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Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
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| 57 | 2021-02-22 | difficulty speaking |
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f...
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Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
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| 57 | 2021-02-22 | balance disorder | Imbalance and confusion |
| 57 | 2021-02-22 | pain | Pounding headache. Chills. Joint aches muscle aches body aches fatigue |
| 57 | 2021-02-22 | involuntary muscle movements, weakness |
Three days after vaccine administration, patient indicates feeling weakness and involuntary movement...
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Three days after vaccine administration, patient indicates feeling weakness and involuntary movements in both legs.
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| 57 | 2021-02-22 | vertigo |
Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1...
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Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1.5 days. But the fields in question 21 would not allow me to enter the information when I checked Hospitalization. I received the vaccination at the Stadium in which was a State run POD.
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| 57 | 2021-02-22 | pain |
developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she als...
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developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she also had fever, chills aches 10 hours after the vaccine and that lasted 24 hours.
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| 57 | 2021-02-23 | dizziness, lightheadedness |
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;...
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I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-02-23 | pain in extremity |
Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck,...
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Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.
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| 57 | 2021-02-23 | pain, pain in extremity |
arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area...
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arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
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| 57 | 2021-02-24 | pain in extremity |
Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable ot...
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Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 22Jan2021 09:00 (at the age of 57years) at single dose for Covid-19 immunization. Medical history included migraine. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen (ADVIL), levothyroxine sodium (SYNTHROID), amitriptyline, rizatriptan benzoate (MAXALT), and butalbital, caffeine, paracetamol (FIORICET); all taken from an unspecified date for an unspecified indication. The patient previously took compazine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 06:00, the patient experienced severe leg and hip pain. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious.
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| 57 | 2021-02-25 | pain, movement disorder, pain in extremity |
bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous...
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bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262 and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included breast cancer. Concomitant medication included letrozole. Patient received the vaccine on Saturday and last night on 25Jan2021 and the morning of 26Jan2021, patient was having a very bad pain in the arm like can barely move it. She was fine until last night. She had a little soreness on Saturday (23Jan2021) and the night of 25Jan2021 and the morning of 26Jan2021, she can barely lift it. The pain was really a lot and patient did not know if this was normal. She knew that there was supposed to be some soreness right afterwards but this was like a day and a half later. Patient took TYLENOL as treatment for the events. Outcome of the events was unknown.
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| 57 | 2021-02-28 | pain |
fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare pr...
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fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare professional (consumer) reported that a 57-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for COVID-19 immunization. On an unspecified date after the second shot, the patient ran a fever and had body aches and chills, which took 2 days to recover. It was unknown if the patient received treatment in response to the event. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 57 | 2021-03-02 | pain in extremity |
About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt...
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About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt blah all day, tired; out of breath; This 57- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on Jan2021 at 12:00 PM (at the age of 57-years-old) as a single dose for COVID-19 immunization, in right arm. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: allergy to pumpkin. Concomitant medication included: Osphena 60mg; VitD 2000IU; Vit C 1000mg; Zinc 50mg. Patient received dose 1 of Pfizer vaccine on a Friday at 12 noon. Felt fine all day. About 3am woke up with chills and a headache. Arm was very sore. Saturday, was very tired/lethargic all day. Slept 10 hrs, awoke with a headache (but no chills) and had breakfast, fell back asleep another 2 hrs, then another 2-hr nap early evening. Felt blah all day, tired and out of breath. Went to bed much earlier than normal. Felt good Sunday but arm still sore. It's Monday at 4pm and arm is still very sore to the touch. The clinical outcome of the events chills, headache, arm very sore, very tired/lethargic, out of breath were recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 57 | 2021-03-05 | speech disorder |
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw...
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I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
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| 57 | 2021-03-07 | pain |
Vaccine received from off site facility. Unknown site or lot number. Patient started to experience...
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Vaccine received from off site facility. Unknown site or lot number. Patient started to experience joint pain the evening of vaccine. Joint pain leading to joint swelling in both knees, wrist and elbow. No fever. Lower leg swelling. Complaint of extreme pain.
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| 57 | 2021-03-10 | nerve pain, dizziness, weakness |
brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; ex...
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brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-03-14 | inability to speak |
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives...
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Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
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| 57 | 2021-03-16 | pain in extremity |
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ...
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Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
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| 57 | 2021-03-20 | pain |
mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contact...
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mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration in the left arm (also reported as left deltoid) on 02Mar2021 12:15 as single dose for COVID-19 immunization. Medical history included obstructive sleep apnea (OSA), hypertension (HTN), obesity from and hypothyroidism. The patient had no known allergies. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID), estradiol and hydrochlorothiazide, losartan potassium (LOSARTAN HCT). No other vaccine in four weeks. The patient experienced mental cloudiness, febrile, fatigued and generalized aches on 03Mar2021. The patient received treatment for the events including Tylenol and work absence. No COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event mental cloudiness cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-21 | vertigo |
Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, so...
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Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, soon was unable to walk due to vertigo, then chills and extreme nausea like I would vomit but I did not.
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| 58 | 2021-01-01 | pain |
I developed symptoms of the corona virus as I had in 3/2020 when I tested positive for COVID-19. I d...
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I developed symptoms of the corona virus as I had in 3/2020 when I tested positive for COVID-19. I developed a headache, fever, aches, chills and extreme tiredness. The symptoms last about 48 hours.
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| 58 | 2021-01-03 | dizziness |
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain...
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30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-03 | numbness |
I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous repor...
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I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.
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| 58 | 2021-01-03 | tremor |
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject...
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The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
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| 58 | 2021-01-03 | dizziness, tremor |
patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; ...
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patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient. A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-01-04 | pain |
24 hours after vaccine developed fever (101), body aches, fatigue. 10 days later still with low gra...
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24 hours after vaccine developed fever (101), body aches, fatigue. 10 days later still with low grade fever (100.3) and fatigue.
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| 58 | 2021-01-04 | dizziness | Dizziness, Light headed, nausea |
| 58 | 2021-01-04 | dizziness, pain in extremity |
Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health profess...
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Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about Lot/Batch number has been requested.
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| 58 | 2021-01-04 | lethargy, dizziness, feeling hot |
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp...
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Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
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| 58 | 2021-01-04 | difficulty speaking |
tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spont...
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tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself. A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation . Medical history included hypertension from an unknown date and blood cholesterol increased. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID). The patient started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event "tested positive for COVID-19, headache, cough, and dysphonia" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-05 | numbness |
Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A...
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Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the right arm on 28Dec2020 07:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes and blood pressure (BP) abnormal. The patient was not pregnant. Concomitant medications included losartan potassium (LOSATAN), metformin, and amlodipine besilate (NORVAC), clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Dec2020 19:00, the patient was sitting and both of her legs became completely numb for 20 minutes and then the symptoms went away. This never happen before. No treatment was received for the adverse event. Outcome of the event was recovered on 29Dec2020 19:20. The event was considered non-serious. Information on the lot/batch number has been requested.
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| 58 | 2021-01-05 | dizziness |
Employee stated she felt dizzy shortly after receiving vaccine. Assessed by RN and EMT's and rested ...
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Employee stated she felt dizzy shortly after receiving vaccine. Assessed by RN and EMT's and rested for 30 minutes then went home.
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| 58 | 2021-01-05 | dizziness |
Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms r...
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Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms resolved after 36 hours.
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| 58 | 2021-01-05 | pain in extremity |
Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old fe...
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Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2, batch number:5926710001), intramuscular in the arm on 30Dec2020 at a single dose for covid-19 immunisation. The patient's medical history included bacterial infection from an unknown date and unknown if ongoing. There were no concomitant medications. On 30Dec2020, the patient got the vaccine and had a little headache and her arms were sore. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 58 | 2021-01-05 | tingling |
LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYS...
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LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYSICIAN
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| 58 | 2021-01-05 | pain in extremity |
Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spon...
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Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient receive first dose of BNT162B2 (lot number: EL1284) on left arm via an unspecified route of administration on 30Dec2020 15:45 at single dose for covid-19 immunisation. Medical history Environmental allergies, diverticulosis, uterine fibroids, and Known allergies: Broccoli and Bell peppers. The patient was previously diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PROTONIX), levocetirizine dihydrochloride (XYZAL), famotidine (PEPCID), fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF). The patient experienced left arm sore around 4 am 31Dec2020. Gradual onset of generalized muscle aches and headache. Worse as day progressed. Xhills late afternoon. Temp at home in evening was 101.2. The patient received tylenol (self administered) for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
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| 58 | 2021-01-05 | weakness | Pfizer COVID vaccine gine. Headsche weakness and extreme conjunctivitis present |
| 58 | 2021-01-05 | dizziness | Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing |
| 58 | 2021-01-06 | dizziness |
Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. ...
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Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. I got help and Sat in office with nurse. My pulse was 140's ,I felt sweaty and shaky. Whole episode lasted approx 10 minutes
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| 58 | 2021-01-06 | pain in extremity |
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third...
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Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
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| 58 | 2021-01-06 | pain |
Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset wors...
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Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and "on fire" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP
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| 58 | 2021-01-06 | vertigo |
Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with ...
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Within an hour of receiving the injection I lost 100% of my hearing in my right ear. Starting with some ringing, vertigo and then just silence. I called the Pfizer hotline, and they took down some information and then directed me to call the COVID hotline which resulted in pretty much the same. As it was Christmas day and the weekend, I waited to contact my Primary Physician on 12/30/20. She saw me immediately and sent me to a Specialist the next day to see Dr. for my hearing loss. There I was given an audiological assessment where my right ear was found to have moderately severe to profound sensorineural hearing loss in the right ear.
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| 58 | 2021-01-06 | weakness, pain | body aches, weakness, sore throat, headache |
| 58 | 2021-01-06 | pain | runny nose, cough, headache and body aches for five days |
| 58 | 2021-01-07 | pain |
12 hrs post injection awoke with shaking chills with fever eventually 102. 2 more episodes of lesser...
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12 hrs post injection awoke with shaking chills with fever eventually 102. 2 more episodes of lesser chills in next 12 hrs, with gradual decrease in fever over 24 hrs to low grade 99. Had severe body aches/joint pains during this time which also slowly improved.
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| 58 | 2021-01-07 | dizziness |
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine...
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5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
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| 58 | 2021-01-07 | dizziness | Bad headache, dizzy, very tired, nausea, blurred vision. |
| 58 | 2021-01-07 | tingling |
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton...
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Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
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| 58 | 2021-01-07 | pain |
Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad t...
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Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.
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| 58 | 2021-01-07 | pain | Fever, to 101.8, chills, body aches, fatigue |
| 58 | 2021-01-07 | pain |
I received my second dose of Pfizer COVID19 in my left arm . It was administered just under the acro...
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I received my second dose of Pfizer COVID19 in my left arm . It was administered just under the acromion process. I am currently experiencing posterior shoulder pain with pain radiating down my arm to my fingers. I have been seen by my primary provider and have been prescribed gabapentin and Tylenol 3. I will follow up with my provider on 01-10-21.
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| 58 | 2021-01-07 | pain in extremity | Severe arm pain. Unable to open and close fingers. Back hurts Chills Cough |
| 58 | 2021-01-07 | pain |
Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ri...
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Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke. The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events.
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| 58 | 2021-01-07 | pain |
Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in...
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Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.
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| 58 | 2021-01-07 | pain | Soreness , fatigue , Arm swollen , Sore to the touch . |
| 58 | 2021-01-07 | pain in extremity |
Start with the normal sore arm continues on day five, normal headache two days. On the second day, v...
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Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
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| 58 | 2021-01-07 | pain in extremity | Vaccine injected too low, causing redness, warmth, swelling and pain at injection site. |
| 58 | 2021-01-08 | pain |
"Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. ...
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"Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. I took Ibuprofen. Symptoms lasted for approximately 36-40 hours.
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| 58 | 2021-01-08 | tingling, dizziness, feeling hot |
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow....
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Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
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| 58 | 2021-01-08 | dizziness | Bad headache, dizzy, blurred vision, nausea, very tired. vomiting. |
| 58 | 2021-01-08 | dizziness | Dizziness, kept patient in observation for 30 min. |
| 58 | 2021-01-08 | numbness, tingling | Facial tingling and numbness, left side of face (same side as shot). Lasted for several hours. |
| 58 | 2021-01-08 | tingling |
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya...
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Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
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| 58 | 2021-01-09 | feeling cold, pain in extremity |
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, ba...
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10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
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| 58 | 2021-01-09 | pain | Chills, body aches Took Tylenol and advil. |
| 58 | 2021-01-09 | dizziness, pain in extremity |
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than ...
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Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
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| 58 | 2021-01-09 | weakness, dizziness |
Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck followi...
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Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.
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| 58 | 2021-01-10 | facial paralysis, bell's palsy |
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye an...
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Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
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| 58 | 2021-01-10 | pain |
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to...
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Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
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| 58 | 2021-01-10 | tingling |
Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symp...
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Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symptoms started on 01/04/2021 is still present, however, patient admits to symptoms improving. Patient received medical care from primary care provider however they could not determine any causes and was advised to keep monitoring the symptoms.
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| 58 | 2021-01-10 | pain in extremity | Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain |
| 58 | 2021-01-10 | pain |
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym...
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Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
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| 58 | 2021-01-10 | dizziness | dizziness, fatigue, vomiting, diarrhea, headache |
| 58 | 2021-01-10 | pain in extremity, feeling cold, weakness |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-11 | pain, weakness, pain in extremity |
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac...
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1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
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| 58 | 2021-01-11 | pain, dizziness | 99 fever, dizzy, nauseous, body aches and pain, headaches, diarrhea. Took Ibuprofen |
| 58 | 2021-01-11 | feeling hot, pain |
About 12 hours after vaccination experienced chills, body aches, intermittent headache and general d...
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About 12 hours after vaccination experienced chills, body aches, intermittent headache and general discomfort. This lasted about 5-6 hours after which there was less aching but could tell that fever persisted, felt sluggish and warm. Temp was 99.9 at the highest over a 2-3 hour period. Ibuprofen was taken about 5 hours after the symptoms started, but only once. Late morning of 01/12 symptoms subsided and felt normal.
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| 58 | 2021-01-11 | pain, vertigo |
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grad...
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Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
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| 58 | 2021-01-11 | dizziness, pain in extremity, pain |
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild...
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Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
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| 58 | 2021-01-11 | pain |
Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatig...
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Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatigue Fatigue only two days after vaccine
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| 58 | 2021-01-11 | pain, dizziness |
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By We...
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Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By Wed evening had chills and low grade fever 99.4. Called out of work Thursday. Felt terrible. Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8. Also felt terrible. Had body aches, could only lay on couch. Called my gastroenterologist. Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form. Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths. Only lasted a few hours. Abdominal pain persisted. Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better. Had to call out of work still too sick to go in. No cough. No fever. Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case. Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night. Still pretty much rested all day into the night. Sunday morning much better. Headache gone and abdominal pain down to a 1 and sometimes just vague. Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes? And new symptoms? right ear crackling and teeth on right side feel sensitive also, pain under left armpit. It's tender and lasts through the day. Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can. Tooth sensitivity also still there but ear pain gone. Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had Covid test today at work (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off". Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity. Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
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| 58 | 2021-01-11 | pain in extremity |
Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old f...
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Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 17Dec2020 at 08:00 AM (at the age of 58-year-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex, magnesium, vitamin D3, and ascorbic acid (VIT C). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020 at 6:00 PM, the patient experienced severe arm pain within hours of the first injection. It was significantly reduced after a dose of Acetaminophen. The event was reported as non-serious. The clinical outcome of the event severe arm pain was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-11 | pain |
Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea-...
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Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea- Covid-19 Symptoms
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| 58 | 2021-01-11 | vertigo |
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ...
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Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
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| 58 | 2021-01-11 | pain, pain in extremity |
Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with...
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Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect. Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well. Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM. Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
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| 58 | 2021-01-11 | dizziness |
c/o throat feels full and tight, dizzy, reacted same way with first vaccine, Benadryl 25mg po given ...
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c/o throat feels full and tight, dizzy, reacted same way with first vaccine, Benadryl 25mg po given at 1438. Patient left at 1505 with no changes in severity, patient states they are ready to go.
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| 58 | 2021-01-11 | weakness, pain in extremity, pain |
chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours...
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chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy. Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
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| 58 | 2021-01-11 | dizziness | dizziness, nausea taking meclizine . Still experiencing dizziness as of 1/12/2021. |
| 58 | 2021-01-11 | numbness, feeling hot, feeling of body temperature change, pain |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-11 | numbness | numbness of the lower extremities |
| 58 | 2021-01-11 | pain, dizziness |
tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste a...
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tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient). The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point. Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.
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| 58 | 2021-01-11 | pain |
very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report...
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very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 28Dec2020. On 01Jan2021, she had very bad joint pain, headache, body pain/ body aches and chills; but no fever, most have gone away but still have back pain. She doesn't have any shortness of breath or fever. She added that she was confused if this was from the vaccine or from Coronavirus and queried what she should I do. She confirmed that she did not get tested for corona virus. She did read that her symptoms could be from vaccine. She also asked that, since she received the vaccine, if it will affect the results of test for corona virus i.e. false positive. The outcome of the events very bad joint pain, headache, body pain/ body aches and chills was recovered on an unknown date in Jan2021 while not recovered for back pain. Information about Batch/Lot number has been requested.
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| 58 | 2021-01-12 | pain |
1/12/21 1:00 AM violent chills, 5:00 AM temperature 102.6, took Acetaminophen. Exhaustion, throbbin...
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1/12/21 1:00 AM violent chills, 5:00 AM temperature 102.6, took Acetaminophen. Exhaustion, throbbing joints. 2:00 PM temperature 101.8, took Acetaminophen, chills, headache, horrible pounding joint pain. 7:00 PM temperature 100.9, chills and exhaustion, took Acetaminophen . 1/13/21 4:00 AM, chills, temperature 100, took Acetaminophen. 9:00 AM exhaustion, massive body aches. 4:00 PM temperature 98.9, chills, exhausted. Have slept about 36-40 hours and lost 2 days of work.
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| 58 | 2021-01-12 | pain |
7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted...
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7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted 24hour, better now
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| 58 | 2021-01-12 | dizziness |
After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of ...
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After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of head. GIven apple juice. Transferred to wheel chair. B/P: 162/105. Pulse ox 98, heart rate 93. . Transferred to bed in holding room. Remained dizzy with headache, B/P 155/93. Pulse ox 100%, heart rate 90. Complained of difficult to breathe laying flat. Elevated HOB to 30. Patient states feeling lik eshe could breathe better. Complains of nausea, but taking sips of water.. Pt has history of hypertension with self-reported baseline of 135/90's. Given water, allowed to rest. At 1421, BP 141/93 but remains dizzy, despite dark environment. At 1427. patient verbalizes still dizzy. Verbalizing stomach upset, nausea. AT 1437, Pt Vomit. B/P 158/105. Report given to ER nurse. Pt transferred to ER at 1450.
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| 58 | 2021-01-12 | pain in extremity | Chills, Headache, Feeling Unwell, Sore Arm |
| 58 | 2021-01-12 | pain | Fever, chills, body aches, fatigue |
| 58 | 2021-01-12 | pain | Headache , Chills, aches and pains, muscle pains, joint pain. Fatigue , had a fever for 18 hours |
| 58 | 2021-01-12 | tingling | Patient reports tingling and burning sensation at the tips of her right fingers. |
| 58 | 2021-01-12 | pain |
Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised ...
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Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised at injection site.; Chills; Low grade fever; Fatigue; Body ache; This is a Spontaneous report from a contactable nurse (reported for herself). A 58-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), intramuscular on 04Jan2021 12:30 at single dose at right arm for COVID-19 immunization. Medical history included Vasculitis, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included azathioprine (IMURAN [AZATHIOPRINE]), chlorthalidone, duloxetine hydrochloride (CYMBALTA), hydroxychloroquine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 14:00, the patient experienced red, hot and raised at injection site. 18 hours after receiving, she developed chills, low grade fever, fatigue and body ache on 05Jan2021. Treatment received for the adverse events included Tylenol. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
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| 58 | 2021-01-12 | dizziness |
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat...
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Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
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| 58 | 2021-01-12 | pain in extremity | arm discomfort and mild headache |
| 58 | 2021-01-12 | pain in extremity |
fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in t...
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fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in the arm; This is a spontaneous report from contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), and multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 17Dec2020 at 08:00 (Lot Number: EK5730; at the age of 58-years-old) for COVID-19 immunization in the left arm and experienced severe arm pain. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 04Jan2021, the patient had tenderness in the arm. The patient took acetaminophen (MANUFACTURER UNKNOWN) which helped. On 05Jan2021, the patient experienced fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the tenderness in the arm and fatigue were recovered on unknown dates in Jan2021.
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| 58 | 2021-01-12 | pain | spiked fever of 101.5 severe uncontrollable chills full body aches nausea |
| 58 | 2021-01-13 | dizziness |
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When...
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"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away. I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it. Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
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| 58 | 2021-01-13 | pain in extremity, pain, dizziness | Arm soreness, headache , body aches, dizzy, ears ringing |
| 58 | 2021-01-13 | pain, pain in extremity | Body Aches, Headache, Sore Arm, Diarrhea |
| 58 | 2021-01-13 | pain |
Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches ...
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Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
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| 58 | 2021-01-13 | vertigo | Vertigo 24 hours |
| 58 | 2021-01-13 | pain, feeling hot, dizziness |
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead...
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Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
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| 58 | 2021-01-13 | pain | woke 15 hours after vaccine with temp 101.5 and body aches. symptom subsided in 8 hrs |
| 58 | 2021-01-14 | pain, dizziness |
1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomi...
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1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomiting uncontrollably. HA. Sx worsened through the night. Felt extremely dehydrated and dizzy. Went to ER on 1/13 in the AM, got IVF, Zofran IV, Phenergan IV, Benadryl, Toradol, Dilaudid. D/C'd home 1/13 Thurs-no nausea, felt achey 1/14 Friday (today)-sore. Feels ok, working from hom.e
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| 58 | 2021-01-14 | vertigo, dizziness |
After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizz...
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After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizzy, but went home. Began to feel nauseated and headache which continued from Saturday through currently. On Wednesday 4:00 a.m woke up to feeling of itchyness in chest. It spread to stomach, then legs, arms, face, back head in about an hour and a half. Took a shower and then felt burning. called doctor next morning at 10:30 and told to start benadryl and allegra. Stared about 1:00 pm. very drowsy and increased headache and nausau. Could still feel burning. Continued with about 3 does. Work up 12:38 on Thursday morning with increased burning and itching and benadryl was last taken 7 and half hours before. Did not take benadryl on Thursday due to drowsyness. Did not work Wednesday or Thursday. Friday early morning hours, woke up several times with itchiness and burning. This is all over my body. No rash at any time. Continued headache and nausea.
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| 58 | 2021-01-14 | tingling |
Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little...
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Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face; This is a spontaneous report from a contactable other HCP. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included Scleroderma, Interstitial Lung Disease, and Raynaud's. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tadalafil (ADCIRCA), amlodipine, pentoxifylline, ASA, and fish oil. The patient experienced diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face that started around 03Jan2021 and was at its worst on 04Jan2021. The patient went to the doctor's office on 05Jan2021. The outcome of the event was recovering. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.
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| 58 | 2021-01-14 | pain | Full body aches, fever to 101, shivers, runny nose Tylenol and Advil |
| 58 | 2021-01-14 | pain in extremity |
Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever...
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Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
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| 58 | 2021-01-14 | tingling |
Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airw...
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Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airway compromise, SOB, CP, or dizziness. Transported to ED from vaccine clinic.
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| 58 | 2021-01-14 | pain in extremity, pain |
Right arm became painful and could not touch or move without lots of pain; Muscle pain; Pain; very a...
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Right arm became painful and could not touch or move without lots of pain; Muscle pain; Pain; very achy all over; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in right arm, on 07Jan2021 at 10:00, at a single dose, COVID-19 immunization. The patient's medical history included hypertension (HTN), exercise induced asthma, allergies to sulfa, and hormones. The patient's concomitant medications included lisinopril, carvedilol (COREG), acetylsalicylic acid (ASA), levothyroxine sodium (SYNTHROID), and unspecified hormones. The patient previously took the first dose of BNT162B2 on 16Dec2020 (also reported as 20Dec2020) at 2:00 PM for COVID-19 immunization (intramuscular in left arm; Lot Number: EK5730). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 at 10 PM (also reported as 7 hours after shot), the patient's right arm became painful and could not touch or move without lots of pain. 1 hour later, the patient went to bed, only to be woken with excruciating muscle pain all over. The patient was unable to lie down, sit, stand, or move without severe pain. The patient took ibuprofen (MOTRIN) and applied heat and lied down on stomach. Within 4 hours, that pain decreased, and the next 24 hours was very achy all over. The patient used heat most of the day. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-01-14 | pain | Severe headache, nausea, fatigue, bodyaches. Unable to work that day after receiving vaccine |
| 58 | 2021-01-14 | pain in extremity |
Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle ach...
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Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle aches (8/10 on pain scale). Headache (4/10). Fatigue. Temperature 100.1. Took Ibuprofen and Tylenol 1st through 5th day. Temperature was under 99.0 by 4th day. Above side effects were bearable with Ibuprofen by 4th day and only arm soreness by 5th day. **Of note, I was diagnosed with COVID on September 11, 2020 and had since recovered.
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| 58 | 2021-01-14 | feeling hot |
reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her...
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reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her left posterior hand from wrist distally to index finger.
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| 58 | 2021-01-15 | swollen extremities | Axilla swelling, Reactive lymphadenopathy |
| 58 | 2021-01-15 | numbness, dizziness |
Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the ni...
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Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the night of the vaccine. Went by ambulance to ED
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| 58 | 2021-01-15 | pain | Fever chills aching and nausea and diarrhea and fever blister |
| 58 | 2021-01-16 | pain, dizziness |
1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, bod...
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1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, body aches, Nausea, T 100.2 F. 1/16/21 0200 took Tylenol 500mg nausea, chills HA T 100.8 at 0410 symptoms continue and I i still had insomnia (that is not uncommon for me) symptoms were a bit milder. 0420 took 500mg Tylenol, 1030 500 mg tylenol HA nausea dizzy T 100.8F. 2345 bad again. took 1000 mg Tylenol and a 3mg tab of Lunesta. body aches HA nausea chill dizzy T 100.7. Overnight I had a bout of terrible night sweat and the bed and pillow and night clothes were soaked (not menapausal related) 1/17/21 0830 T 97.8 feel a bit better. as the day goes on I notice when I move around, especially quickly I have a horrible pain in my head and dizziness. at 1700 T99.9 nausea, dizzy HA.
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| 58 | 2021-01-17 | pain in extremity | ARM PAIN, FEVER 101, JOINT PAIN FOR 24 HRS. TOOK TYLENOL 500MG 2 TABLETS |
| 58 | 2021-01-19 | tenderness |
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21...
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1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
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| 58 | 2021-01-19 | pain | Chills, seizure like activity, body aches, injection site soreness |
| 58 | 2021-01-19 | pain |
Fatigue, headache, fever (99.9- 100.9), body aches Fatigue started 5 hours after receiving vaccine; ...
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Fatigue, headache, fever (99.9- 100.9), body aches Fatigue started 5 hours after receiving vaccine; Fever, body aches & headache started about 8- 10 hours after receiving vaccine. Lasted until 36 hours after receiving vaccine
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| 58 | 2021-01-19 | unresponsive to stimuli, pain |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-19 | feeling cold, tingling |
Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes ...
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Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes after receiving vaccine and lasted 45-60 minutes.
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| 58 | 2021-01-19 | pain in extremity |
On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home,...
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On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020 Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore. That continued on through that night and into the next morning. So I had to call in at work that morning 1/14. I finally started feeling better by friday night, 1/15. The headache was gone and the chills were only slight and I could finally keep some toast down. Before that I could only slightly keep liquids down.
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| 58 | 2021-01-19 | vertigo | Systemic: Rash (other than injection site)-Mild, Systemic: Nausea-Severe, Systemic: Vertigo-Severe |
| 58 | 2021-01-21 | dizziness | Bad headache with severe dizziness began a little over 24 hours after my second shot. |
| 58 | 2021-01-21 | dizziness |
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v...
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Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
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| 58 | 2021-01-21 | pain, pain in extremity |
On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen ...
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On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen - slight headache. On 1/21 3:45am right eye swollen, (but not swollen shut) a little ache -slight headache.
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| 58 | 2021-01-21 | dizziness |
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy bu...
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Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms. We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
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| 58 | 2021-01-21 | migraine | Sick to stomach, migraine head ache |
| 58 | 2021-01-21 | pain, dizziness |
This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-o...
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This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
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| 58 | 2021-01-23 | pain |
On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At ar...
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On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At around 2:30 on Jan 23 I had an argument with someone and felt my heart race for a minute and then chest pain radiating to my back. Went to the hospital at 7pm and was being ruled out for an MI.
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| 58 | 2021-01-24 | pain, weakness |
24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hour...
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24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hours, then slight headache and weakness continued an additional 12 hours.
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| 58 | 2021-01-24 | dizziness |
Chills and dizziness for about 3 days after the shot, no medical treatment required but plenty of b...
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Chills and dizziness for about 3 days after the shot, no medical treatment required but plenty of bed rest and hot liquid.
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| 58 | 2021-01-24 | dizziness |
Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had ...
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Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
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| 58 | 2021-01-24 | vertigo |
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours sev...
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Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
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| 58 | 2021-01-24 | pain |
Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or ki...
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Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or kidney stones)
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| 58 | 2021-01-25 | dizziness | Fever, chills, dizziness, all began 23 hours after 2nd dose, subsided 12 hours later at 10 pm |
| 58 | 2021-01-25 | pain |
First fatigue, then headache, progressing to chills with fever up to 102 lasting approximately 24 ho...
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First fatigue, then headache, progressing to chills with fever up to 102 lasting approximately 24 hours, body/joint aches, deep cough, felt like I couldn't get a deep breath (shallow breathing)
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| 58 | 2021-01-25 | nerve pain | Nerve pain on her back. It is in the same spot where she had previously had shingles pain |
| 58 | 2021-01-25 | dizziness |
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAI...
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PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN. ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,. PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS. VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC. SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.
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| 58 | 2021-01-25 | weakness, pain |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received firs...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
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| 58 | 2021-01-25 | pain |
body ache/ all over achy feeling; muscle aches; feeling like coming down with the flu; This is a spo...
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body ache/ all over achy feeling; muscle aches; feeling like coming down with the flu; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on left arm at 11:45 AM on 22Dec2020 at single dose for COVID-19 immunization. Medical history included Graves Disease and COVID-19 (Prior to vaccination, diagnosed with COVID-19). Concomitant medication included ibuprofen (MOTRIN), diclofenac sodium. The patient previously took percocet and experienced allergies, darvocet and experienced allergies. The patient experienced body ache and muscle aches the day after first shot also feeling like coming down with the flu all over achy feeling on unknown date that resolved in a days time. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.
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| 58 | 2021-01-26 | vertigo |
Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a ...
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Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 06Jan2021, the patient experienced severe vertigo. Patient also experienced headache, congestion (sinus) on an unspecified date. On 05Jan2021, patient experienced vomiting and nausea. Patient stated that she went to her primary care and was given patch for nausea and was given a different sinus brand to clear up the congestion. Patient stated that with all these, she is pretty sure that she does not want the second dose. Patient stated that she has symptoms of the vaccine than rather COVID and wanted to know what were the recommendations. The outcome of the event congestion (sinus) was not recovered, vomiting was recovered 05Jan2021, while the other events was recovering.
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| 58 | 2021-01-26 | migraine, pain |
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ...
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Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
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| 58 | 2021-01-26 | tenderness, pain |
Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move m...
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Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move my neck, and is very tender to touch. It is still present now, 10 days after receiving the vaccination. I saw my MD today who assured me it is a typical appearance for a lymphadenopathy, but it still bothers me, especially never having had such an occurrence before.
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| 58 | 2021-01-26 | pain |
extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through ...
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extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through morning. I took my temp on 1/21 at 9am and it was normal. (98.4) Body aches, and nausea most of the day on 1/21/2021. treatment: Ibuprofen 600mg BID X 2 days.
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| 58 | 2021-01-28 | pain in extremity |
2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (l...
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2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (level 9). I began taking Tylenol which caused the pain to subside to a reasonable level. I took Tylenol every 6 hours to keep the pain in my arm, which seemed to cause some neck stiffness, down to a 2 or 3 level (10 being the worst pain). The next morning pain was down to 1 or 2 level, I took Tylenol again. By noon the second day pain was gone.
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| 58 | 2021-01-28 | pain | HA, BODY ACHE, FATIGUE |
| 58 | 2021-01-28 | dizziness, tingling |
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat...
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Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
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| 58 | 2021-01-28 | speech disorder |
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the...
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Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
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| 58 | 2021-01-28 | pain | Temo 101. body aches headache |
| 58 | 2021-01-28 | pain | sore body and muscles, vaccine site extremely sore headache and fatigue. |
| 58 | 2021-01-30 | unresponsive to stimuli |
After being observed for approximately 20 minutes and patient walked to her car without assistance I...
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After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
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| 58 | 2021-01-31 | difficulty speaking |
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E...
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chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
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| 58 | 2021-02-01 | unresponsive to stimuli |
Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfa...
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Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.
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| 58 | 2021-02-04 | weakness |
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita...
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Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
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| 58 | 2021-02-13 | numbness, tingling, pain in extremity |
My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI...
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My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief. My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.
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| 58 | 2021-02-21 | dizziness |
Pt began to fell dizzy about one minute after her injection. Patient remained at vaccine table. De...
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Pt began to fell dizzy about one minute after her injection. Patient remained at vaccine table. Denies any additional symptoms. Dizziness resolved after 5 minutes, vitals declined.
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| 58 | 2021-02-21 | pain in extremity, pain |
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ...
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The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
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| 58 | 2021-02-21 | migraine | soreness at injection site. then a mild migraine the following evening. |
| 58 | 2021-02-22 | pain |
shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is ...
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shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now. The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-23 | feeling hot, dizziness |
Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the ...
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Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the patient care tent. BP: 128/70, P: 90, Resp: 17. Patient drank some water and ate pretzels while sitting and denied dizziness after 20 minutes of sitting up. Patient left the building feeling well and denied any dizziness.
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| 58 | 2021-02-23 | pain in extremity, pain, tingling, numbness |
had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that...
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had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.
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| 58 | 2021-02-24 | pain |
Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on lef...
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Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; This is a spontaneous report from a contactable nurse (patient herself). A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3303, expiration date was unknown), intramuscularly in the left arm on 27Jan2021 at 12:30 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiration date was unknown) on 06Jan2021 at 12:45 AM, intramuscularly in the left arm for COVID-19 immunization. The patient had no medical history. The patient had no known drug allergies (NKDA). There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced pain on left side especially in her neck swelling at her left clavicle painful to touch, which was assessed as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
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| 58 | 2021-02-25 | migraine |
continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneou...
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continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 58 | 2021-02-28 | tingling |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT1...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration by injection once to left arm, upper part, on 26Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced tingling on right side by cheek bone on 27Jan2021 and she did not have it yesterday, and the shot was on the left side, later clarified as the left arm. The outcome of the event was not recovered.
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| 58 | 2021-03-02 | pain |
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and ...
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High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
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| 58 | 2021-03-02 | weakness |
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a s...
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slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
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| 58 | 2021-03-03 | pain |
Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom...
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Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom; the sores are underneath the lip by the cheek on top and bottom/sores being white on top and real red where the bump is, but on top of it, it's really white; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 30Jan2021 11:30 at a single dose for COVID-19 Immunization. Medical history included Hashimoto's thyroiditis and acid reflux. Concomitant medication included levothyroxine for Hashimoto's thyroiditis and pantoprazole for acid reflux. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL1283; expiration date: Apr2021) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 09Jan2021 at a single dose for COVID-19 Immunization. The patient reported that she got her second shot on Saturday 30Jan2021 and yesterday (01Feb2021), her lips were swollen, and she has sores inside the mouth, the sores are underneath the lip by the cheek on top and bottom. She further reported that swelling was on both top and bottom lips, it occurred yesterday 01Feb2021, she noticed it as soon as woke. The sores in the mouth also started at the same time. She added that the lips swelling is ongoing but getting better. The Sores in the mouth, she thinks that they are getting better but it does bother her more when she is eating, but it is getting better, she only experiences pain on the sores when she is eating but other than that there is no pain. She has not used anything to treat the swelling and sores. The sores are sensitive to touch. She described the sores being white on top and real red where the bump is, but on top of it, it's really white. She has had no positive COVID Test prior to the first dose. She has had no issues with vaccines in the past. She also added that she did have chills and body aches on Saturday (30Jan2021) and Sunday (31Jan2021), she thought she was doing great, but then on Monday the sores showed up. She wanted to report this because no one said to her that would happen. She clarified that she experienced the chills on the same day of getting the second dose on 30Jan2021, then the body aches came Sunday 31Jan2021. The outcome of the events chill and ache were unknown while the outcome of the other events was recovering.
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| 58 | 2021-03-03 | pain |
between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble ...
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between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble catching my breath which I thought was due to shoveling heavy snow, then received my 2nd dose on 2/9/21 and on 2/14/21 I couldn't breathe and pain was so intense and went to Hospital at 9:30 PM and stayed overnight
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| 58 | 2021-03-03 | weakness, pain |
zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous...
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zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration single dose arm left on 29Jan2021 09:00 (at the age of 58) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced zapped of energy on 31Jan2021 16:00, chilled on 31Jan2021 16:00, body aches on 31Jan2021 16:00, mild sore throat on 31Jan2021 16:00, slept about 15 hours on 31Jan2021 16:00. No treatment administered. The events outcome was recovered.
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| 58 | 2021-03-07 | dizziness, migraine |
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila...
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felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-03-10 | dizziness |
2/27. Spontaneous subdural hematoma. Occurred 30 minutes into a flight. Headache and dizziness be...
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2/27. Spontaneous subdural hematoma. Occurred 30 minutes into a flight. Headache and dizziness began one week prior to 2/27, but not sure if they are correlated.
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| 58 | 2021-03-14 | bell's palsy | Bell's Palsy |
| 58 | 2021-03-14 | pain, dizziness |
First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure;...
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First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure; This is a spontaneous report from a contactable consumer. A 58 -year-old female (not pregnant) patient received her first dose on an unspecified date, second dose (lot number: EN2601) on 12Feb2021 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration (at the age of 58 -years-old), single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included clonazepam. The patient experienced First chills, vomiting, body aches, head pressure, severe dizziness and vomiting. Head still doesn't feel normal (The events were reported also to happen then 12 days later), all events started 23Feb2021 0600. The outcome of the events was recovering. The events were reported to cause 3 days hospitalization. No other vaccine in four weeks. AE Treatment: Meclizine, Zofran, EKG, MRI, CT of head. The patient had a covid swab test on 23Feb2021 with negative result.
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| 58 | 2021-03-14 | tingling |
She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her h...
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She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-03-16 | pain in extremity |
swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks...
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swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks painful/Fingers hurting, I am cutting and dropping things more frequently; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9899) intramuscularly in the left arm on 26Dec2020 at 08:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included migraine from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received epinephrine on an unspecified date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 06:00 the patient experienced swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently. The events all resulted in doctor visits and were all serious for disability or permanent damage. The clinical course was reported as follows: "I developed swollen fingers, joint started hurting. My both hand fingers were drum sticks painful (as reported). I had no idea what was going on, things getting my ankle knees (as reported). I consulted internal medicine; I was referred to Rheumatology Clinic. All blood work was negative. All serology testing done was negative. Joints hurting. The doctor asked me to start taking Motrin which made my situation worse. I gave up. Miserable situation. I consulted another FPC who advised I give it time. I cannot hold fine item. Fingers hurting, I am cutting and dropping things more frequently. I am a healthy person. No medication. No complications." The patient asked if there were any solutions. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9231) intramuscularly in the left arm on 15Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. The patient received treatment for the adverse events which included Ibuprofen 400mg for pain. The clinical outcomes of the events swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-03-21 | pain, pain in extremity |
acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pai...
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acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported. 4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
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| 58 | 2021-03-22 | pain in extremity, pain |
Severe pain throughout body but especially in the back radiating into right leg Wednesday, Thursday,...
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Severe pain throughout body but especially in the back radiating into right leg Wednesday, Thursday, Friday, Saturday nights to present. Leg weakness Saturday to present.
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| 58 | 2021-03-22 | weakness |
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co...
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faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 58 | 2021-04-01 | pain, weakness, dizziness, lethargy |
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte...
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3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
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| 59 | 2020-12-31 | tingling, dizziness, numbness |
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE...
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DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
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| 59 | 2020-12-31 | weakness |
High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness a...
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High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days
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| 59 | 2021-01-01 | pain, pain in extremity |
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a...
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Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
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| 59 | 2021-01-01 | pain, pain in extremity |
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 h...
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I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
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| 59 | 2021-01-03 | numbness, tingling |
Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling...
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Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling like when you get anesthesia from a dental procedure and it is thawing out. It was just the left side of my face, same side I got the vaccine. Could feel a dividing line in the middle of my face. It lasted with the same intensity for 3 days. It then started to subside slowly for the next 3 days and then was totally gone.
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| 59 | 2021-01-03 | numbness |
I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (a...
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I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.
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| 59 | 2021-01-03 | pain |
Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after t...
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Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after taking again later. Contacted physician and advised to come in. Different BP med given that helped. Woke up tired the next morning.
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| 59 | 2021-01-04 | numbness, dizziness, tingling |
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ...
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Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
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| 59 | 2021-01-04 | pain |
Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose ...
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Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose Tenderness at the injection site.
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| 59 | 2021-01-04 | tingling |
Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED...
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Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.
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| 59 | 2021-01-04 | pain |
Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at t...
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Patient's reaction(s) noted during COVID vaccine observation period: Redness, swelling, or pain at the injection site, extending >2cm diameter area(states it feels like it's in her bones). Pain worse with movement. No redness/swelling. Actions Taken: VS taken and WNL, with the exception of BP being a little high for her. She was offered the opportunity to go to ED and declined saying that it is manageable and will take Tylenol. Â Disposition: Patient declined ED visit
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| 59 | 2021-01-04 | pain |
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit ...
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pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.
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| 59 | 2021-01-05 | swollen extremities, dizziness, weakness |
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ...
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1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
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| 59 | 2021-01-05 | swollen extremities, pain, dizziness, tremor |
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ...
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6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
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| 59 | 2021-01-05 | lightheadedness, dizziness | Extreme Dizziness, Blurry Vision, Near fainting and Nausea |
| 59 | 2021-01-05 | weakness | Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea. |
| 59 | 2021-01-05 | feeling hot, pain in extremity |
It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the s...
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It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the shoulder to the neck is painful; Her whole arm is sore up to her neck and down the arm/It is very painful/it throbs; Last night she was up all night, every 3 hours; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiration date Apr2021), via an unspecified route of administration at left arm on 30Dec2020 09:30 at single dose for COVID-19 immunization, at a hospital. The vaccine was not administered at military facility. The patient's medical history included ongoing asthma from 2005 (diagnosed 15 years ago) and allergies. For asthma She has ProAir rescue inhaler to use as needed. Breo inhaler she uses at night. She has been on it for 2 years. She has been on different inhalers. Family medical history relevant to events was reported as none. Concomitant medication included montelukast sodium (SINGULAIR) from 2005 (had been on it probably 15 years) and ongoing at 10 mg, daily for allergies; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler via resp Inhalation from 2018 (has been on it for 2 years), uses it at night, for asthma; and salbutamol sulfate (PROAIR HFA) rescue inhaler via resp Inhalation, to use as needed for asthma. The patient had no history of previous immunization with the Pfizer vaccine. For historical vaccine, the patient received Tetanus for immunization and had allergic to Tetanus, her arm swelled and she couldn't move it (which was kind of like this, but not as severe). She didn't know the brand name for the tetanus vaccine she had reaction to. She didn't have NDC, lot, or expiry. It was 40 years ago. She had the reaction when she was 18 years old. There was no vaccine administered on same date of the Pfizer suspect, and tno vaccinations within 4 weeks prior to the Pfizer suspect. It was reported that last night (30Dec2020) she was up all night, every 3 hours. She was taking Advil. Her whole arm was sore up to her neck and down the arm. She had a nurse look at it this morning (31Dec2020) and it was not red. It was warm and it throbs. No rash. It was very painful. Even up to the back of the shoulder to the neck was painful. Her arm being sore and painful was ongoing at the time of report. She had been taking Advil. The pain had stayed the same even with the Advil. The events started probably between 14:00 and 14:30, it started off sore then became more painful. At the time of reporting, she was not at home and didn't have the bottle to provide NDC, lot, and expiry for Advil. She was taking some at the office, but that was in a travel bottle and didn't have the lot, expiry, and NDC. No emergency room or physician office visit. Relevant tests was none. The outcome of the events was unknown.
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| 59 | 2021-01-05 | dizziness |
It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain ...
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It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain just seems to be getting worse; Dizziness/Lightheaded; Headache; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine; lot number: EL3246; expiration date: unknown), via an unspecified route of administration left upper arm on 30Dec2020 11:30 AM at a single dose for Covid-19 vaccination. The patient has no medical history and concomitant medications. The patient reported that she got her first dose of Pfizer vaccine (COVID-19 Vaccine) yesterday (30Dec2020) and today (31Dec2020), she was having at first it was like mild lower back pain like on the lower left part of her back, on top of her buttocks and now it's getting worse. The patient inquired if it was like a side effect. The patient further stated that yesterday (30Dec2020), she had a side effects like the dizziness, lightheaded and the headache and that went away after she took Tylenol (treatment) but then today this pain just seems to be getting worse. The paracetamol (TYLENOL) was given to her at hospital yesterday for the headache and the dizziness. She hasn't taken anything today because she was not sure if it is okay for her to take Ibuprofen which is what she would prefer to take. She received her COVID-19 Vaccine at a hospital. The outcome of the events was not recovered.
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| 59 | 2021-01-05 | numbness, tingling |
Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes afte...
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Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes after injection which has extended into hand 48 hours after injection
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| 59 | 2021-01-05 | lethargy, lightheadedness, dizziness, weakness |
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness...
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Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
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| 59 | 2021-01-05 | dizziness, tingling |
This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had g...
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This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay. She got up to walk outside and started feeling dizzy. Her hands felt tingly. She also felt a little short of breath. She came back in and sat down and the symptoms did not seem to really improve. She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: " The patient did feel much better after just being observed here and after getting Benadryl." She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.
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| 59 | 2021-01-05 | weakness, pain |
Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with...
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Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina. Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.
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| 59 | 2021-01-05 | pain |
Woke up the following morning with terrible body aches, especially to upper back, neck, lower back a...
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Woke up the following morning with terrible body aches, especially to upper back, neck, lower back and legs. Headache, diarrhea, and tiredness. Was unable to "function", and slept most of the day. Was still having some of those symptoms the second day, but not as bad.
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| 59 | 2021-01-05 | pain in extremity |
made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (p...
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made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history was concomitant medications were not reported. The patient stated, "where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect." The outcome of the event was unknown. Information on lot/batch number was requested.
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| 59 | 2021-01-06 | pain | CHILLS, BODY ACHES |
| 59 | 2021-01-06 | pain | Fevers, chills, aches & pains |
| 59 | 2021-01-06 | pain in extremity |
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho...
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Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
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| 59 | 2021-01-06 | dizziness, difficulty speaking | Patient felt dizzy quickly progressed to hoarse voice, cough and expressed difficulty breathing |
| 59 | 2021-01-06 | pain |
Severe headache came on suddenly. Neck, shoulder and body aches Extreme fatigue NO elevated temperat...
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Severe headache came on suddenly. Neck, shoulder and body aches Extreme fatigue NO elevated temperature
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| 59 | 2021-01-06 | numbness, tingling |
Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/...
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Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/6 eve, approximately 10 pm, noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).
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| 59 | 2021-01-06 | dizziness |
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore...
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stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
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| 59 | 2021-01-07 | pain |
1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body...
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1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body aches. Thursday night had a low grade temp and the headache got severe and she developed lymph node swelling in R axilla. She continues with headache that is bad and body aches but no fever today 1-8-2021
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| 59 | 2021-01-07 | pain in extremity, pain in extremity |
3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and ...
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3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.
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| 59 | 2021-01-07 | pain in extremity |
CDC called and requested I complete this report, but I do see these reactions within the normal rang...
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CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine. 6 hrs after 2nd shot fever of 99, headache, and arm pain. 20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day. 30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.
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| 59 | 2021-01-07 | pain |
Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tyleno...
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Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tylenol. Had to miss a day of work. Have lingering fatigue and headache after 2 days. Also morning after vaccination had about 5 minutes of tachycardia with HR of 165 bpm. Resolved after taking blood pressure which was 114/69 with HR of 85 bpm. No further episodes.
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| 59 | 2021-01-07 | vertigo, tingling |
Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizzi...
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Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizziness upon standing and reported tingling in lower limbs. Patient was monitored for an additional 20 minutes and symptoms resolved. Patient had no other complaints.
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| 59 | 2021-01-07 | numbness, pain in extremity, tingling |
From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbnes...
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From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
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| 59 | 2021-01-07 | feeling cold, tremor |
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ...
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Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
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| 59 | 2021-01-07 | pain in extremity |
Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontan...
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Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events 6 patients. This is 2nd of 6 reports. A 59-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. This patient had a low grade temperature that last 6 hours, nausea, vomiting and diarrhea on 05Jan2021. She also experienced the arm soreness on 29Dec2020. patient says that they had employees get the COVID Vaccine on 29Dec2020. Most said that they maybe got a little arm soreness that lasted a few hours. They took tylenol and were fine. reporter confirmed that this patient is herself. She did not have a specific physician that she sees. She sees whoever is there that day. She received the vaccine on 29Dec2020. These symptoms hit her early this morning. They hit her, then she called out of work. She talked to her provider and they were going to revisit if they wanted to do another COVID test. she has already had two negative tests. Treatment was none. Patient states she just got off the phone completing a report of side effects from several of her employees that happened within 24 hours of receiving the Covid vaccine on 29Dec2020. reporter states several employees reported headaches, tiredness, and malaise. reporter would like to know if the onset and duration for these symptoms are expected. Her question it, since they all got the vaccine on 29Dec2020, would they be experiencing these side effects 7 days post injection, this far out. No Investigation Assessment. Patient was recovered from low grade temperature that last 6 hours, vomiting and diarrhea on 05Jan2021, recovered from arm soreness on 29Dec2020, recovering from nausea. Reporter seriousness of low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was not serious. The reporter considered the events Low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was related. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | pain in extremity |
Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous re...
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Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported events for 6 patients. This is a 1st of 6 reports. A 59-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 29Dec2020 at single dose, once by injection in the right arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on 30Dec2020 that lasted a few hours, malaise and extreme tiredness on 05Jan2021. Therapeutic measures were taken as a result of arm soreness included Tylenol. The patient worked in a healthcare facility and had not had COVID. The outcome of event arm soreness was recovered on 30Dec2020, and of malaise and extreme tiredness was not recovered. Reporter seriousness for arm soreness, malaise and extreme tiredness was non-serious. The reporter considered the events arm soreness, malaise and extreme tiredness were related to COVID Vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006243 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006329 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006376 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006151 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021005968 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | migraine |
Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse...
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Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
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| 59 | 2021-01-07 | numbness | Numbness on the left side of face and ear. Lasted only about 4 hours from about 5pm to about 9pm. |
| 59 | 2021-01-07 | dizziness |
This 59 yo contractor was referred to for HA, dizziness and nausea after her first COVID vaccine. S...
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This 59 yo contractor was referred to for HA, dizziness and nausea after her first COVID vaccine. She received Pfizer COVID vaccine on 12/31/2020. She advised 8 hours later she developed a severe headache. She advised she took 800 mg Ibuprofen and 4 hours later took 1000mg Tylenol and was able to go to sleep. She awoke the next day with her headache persisting and was nauseated. She stated she would alternate Ibuprofen and Tylenol every 4 hours and drink gatorade/water (appetite was low and didn't eat). She denied any fever, rash, SOB, arthralgia, myalgia or other systemic symptoms. Day 4 post vaccination (1/4/2021) she cut med use down to every 8 hours. She stated use of Ibuprofen/Tylenol did resolve
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| 59 | 2021-01-07 | weakness, pain |
Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slig...
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Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slight nausea. Notified supervisor at work, took Tylenol 1000 mg and slept for 2.5 hours. Woke up with symptoms much reduced and went to work
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| 59 | 2021-01-07 | pain in extremity, weakness |
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar...
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Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
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| 59 | 2021-01-07 | pain | body aches, sore throat, chills just doesn't feel well |
| 59 | 2021-01-07 | pain |
sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well...
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sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well, hives
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| 59 | 2021-01-07 | tingling | tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called |
| 59 | 2021-01-08 | pain |
About 6 hours after my second injection I started with a headache,bodyaches,low grade fever,chills. ...
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About 6 hours after my second injection I started with a headache,bodyaches,low grade fever,chills. They lasted about 48 hours. Still have pain in my armpit on left side.
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| 59 | 2021-01-08 | tremor |
Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted...
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Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted & interviewed (Dr.) patient. Ambulance called. Vitals re checked Benadryl 25 mg PO given. Paramedic & Ambulance arrive 4:35 59 y/o who states she had anaphylaxis before her symptoms started the same as today. C/o quivering lips & H/A No rash or respiratory comp (EMT's exam - normal except ? movement. Assessment - Possible allergic RXN Plan - Ambulance transport to ED
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| 59 | 2021-01-08 | pain | temperature 100.2 chills and body ache and headache |
| 59 | 2021-01-09 | dizziness |
Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked th...
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Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked the next day was ok. Started driving the next day on interstate 12/25/20, and had chest pressure. Pulled of in to a hospital their and had testing done. Went home had dizziness still. Went to her MD, the doc changed her blood pressure meds. She doesn't have the dizziness and the chest pressure any more. Blood pressure is still high and monitoring it a few times a day.
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| 59 | 2021-01-09 | pain, feeling hot, tingling |
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210...
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I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
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| 59 | 2021-01-09 | pain |
Six hours after being administered by the vaccine I started to feel soreness around the site. Within...
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Six hours after being administered by the vaccine I started to feel soreness around the site. Within the hour it progressed to pain in my left upper arm radiating down to my lower arm. By this time, I had difficulty raising my arm and limited ROM. This continued for three days. The symptoms eased up a little bit but there was constant pain whenever I raised my affected arm. When I went to work on the night of the Jan third, I felt my arm hurting during the night. I took ADVIL for the pain and continued to do so. Jan 6 and 7 At night, I was awoken with excruciating pain on the same arm. This lasted for approximately a couple of mins. I sought a virtual consultation with my PCP who advised me to take ten days off from work. I am currently on medical leave. I haven't experienced the same excruciating pain as I had those two nights. However, my ROM is still limited because there is still moderate pain involved. I've stopped taking Advil since it has started to upset my stomach.
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| 59 | 2021-01-09 | pain | Temperature 99.4, severe body aches, chills, soreness at injection site |
| 59 | 2021-01-10 | pain in extremity, pain |
06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than t...
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06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T
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| 59 | 2021-01-10 | pain | 40 hours of chills, and body aches and headache |
| 59 | 2021-01-10 | pain in extremity |
Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen ar...
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Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen area where shot was given
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| 59 | 2021-01-10 | dizziness | Dizzy, chills, tired, resolved with nap |
| 59 | 2021-01-10 | pain in extremity | Hand Pain |
| 59 | 2021-01-10 | numbness |
Patient experienced right eyelid and cheekbone numbness following the first dose. She received her s...
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Patient experienced right eyelid and cheekbone numbness following the first dose. She received her second dose 11 days after the first in error. Following the second dose, she reported cheek numbness and nausea, which had resolved when I spoke with her on 1/11/21.
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| 59 | 2021-01-10 | numbness |
Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 ...
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Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 days later instead of 21 days). The patient reported experiencing right eyelid and cheekbone numbness and a minor headache after the first dose. She had numbness to her right cheek again on 1/8/21 and some nausea that has resolved. I spoke with the patient on 1/11/21 and she is feeling well.
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| 59 | 2021-01-10 | tremor |
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen...
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She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-10 | pain in extremity |
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw...
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That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
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| 59 | 2021-01-10 | tingling, pain in extremity |
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o...
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sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
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| 59 | 2021-01-10 | pain in extremity |
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o...
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soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-11 | dizziness |
1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke f...
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1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke feeling same. I took routine vitamins and 2 extra strength Tylenol. Symptoms lasted all day with difficulty walking due to the dizziness. Also had difficulty focusing, blurry vision. 1/6/2021 still a little lightheaded just a little dizzy. Headache ( I have routine headaches). lightheaded and dizziness decreased with each day.
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| 59 | 2021-01-11 | weakness, pain |
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21...
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12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
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| 59 | 2021-01-11 | numbness, tingling, swollen extremities |
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev...
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After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
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| 59 | 2021-01-11 | pain in extremity | Arm aching Fatigue Minor hives for three days Treated with Zyrtec and Benedryl |
| 59 | 2021-01-11 | pain | Body aches, Headache, Nausea |
| 59 | 2021-01-11 | dizziness |
Feeling light headed and dizzy. Given water and crackers. Rested and monitored for 30 minutes. Left ...
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Feeling light headed and dizzy. Given water and crackers. Rested and monitored for 30 minutes. Left walking without difficulty.
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| 59 | 2021-01-11 | feeling cold, tingling |
Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and ...
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Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and then goes away. Some tingling in upper extremities noted initially , but none now. Patient declined to remain longer for observation. She had her husband here for transportation home. Advised patient to call Health Services if other symptoms occurs She will do this. Advised ER if symptoms emergent.
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| 59 | 2021-01-11 | pain | developed body aches and nausea |
| 59 | 2021-01-11 | tingling, numbness |
numbness in right fingers along with tingling. moved to back of neck and side of face. right side ...
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numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 59 | 2021-01-11 | dizziness |
patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID va...
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patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID vaccine - her blood pressure was elevated as well - she reports she had not taken her blood pressure medication prior to the vaccine. Patient received Acetaminophen and Lisinopril in Emergency Dept afterwards and discharged home.
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| 59 | 2021-01-11 | dizziness, lightheadedness | pre syncope; difficulty breathing; dizzy - after 20 minutes of monitoring patient refused emt |
| 59 | 2021-01-12 | pain |
-FEVER 101, BODY ACHE, HEADACH, FATIGUE, RUNNY NOSE , - Began within 6 hours Naprosyn helped, Tyleno...
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-FEVER 101, BODY ACHE, HEADACH, FATIGUE, RUNNY NOSE , - Began within 6 hours Naprosyn helped, Tylenol did not. TXT symptomatically with Pepcid, Claritin, tylenol, Naprosyn
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| 59 | 2021-01-12 | dizziness |
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter...
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1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
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| 59 | 2021-01-12 | pain in extremity |
Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under...
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Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under both of her breasts as well as her face, scalp. She felt " flushed". No tongue or lip swelling, No wheezing. she had arm soreness and muscle " weakness" in the left arm after dose #1 and completed a VAERS form at that time but had completely recovered prior to receiving injection #2
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| 59 | 2021-01-12 | pain | Fatigue. Injection site pain. Chills. Body aches, headache, nausea. Resolved. |
| 59 | 2021-01-12 | pain |
Fever- started at 99.4 (5:00 a.m.) increased to 100.8 within an hour. Roughly about 2 hr increments...
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Fever- started at 99.4 (5:00 a.m.) increased to 100.8 within an hour. Roughly about 2 hr increments the fever started to reduce 100.6, 99.6, 99.0, 98.7 to normal with no fever reducer medication. Body aches- started when temp got to 100.8 and lasted about 12 hrs. Tired- started after temp was reduced to normal and gradually got more tired as the day went on. Woke the next day with no symptoms
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| 59 | 2021-01-12 | pain in extremity |
Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:3...
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Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:30 in right deltoid. Pt tolerated dose #1 in left deltoid. She developed mild arm " weakness" and soreness that lasted several days. She completed a VAERS report after her first dose. She began to feel " itchy all over" at 15:00. She noticed hives under her bilateral breasts. She felt " flushed" and her scalp and face felt itchy as well. No SOB or CP. NO wheezing. She has a hx of allergies to KEFLEX/PCN.
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| 59 | 2021-01-12 | tingling |
Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving he...
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Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving her arms around to prevent soreness and then both arms began to feel itchy, tingling, & burning & this moved up into her neck. She was encouraged to come in and be seen, but she does not feel that is necessary at this time. She reported her symptoms have since improved and that she had a similar reaction when she received the shingles vaccine. I encouraged patient to monitor her symptoms and to come be seem if she gets worse. She reported that she is feeling much better at the end of our phone call.
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| 59 | 2021-01-12 | dizziness, dizziness |
Patient received her first dose of Pfizer vaccine on 1.12.2021. Patient reports that she woke up at ...
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Patient received her first dose of Pfizer vaccine on 1.12.2021. Patient reports that she woke up at 0230 on 1.13.21 with extreme dizziness. Patient says at 0530 she woke up again, still dizzy, but improved. Once she came to work at 0800, she felt normal again. Patient will call back again with any changes.
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| 59 | 2021-01-12 | tremor |
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ...
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Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
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| 59 | 2021-01-13 | tremor |
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking o...
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1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
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| 59 | 2021-01-13 | weakness |
Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weak...
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Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weakness
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| 59 | 2021-01-13 | pain | Injection site pain/soreness, body ache. |
| 59 | 2021-01-13 | feeling hot |
Patient began to experience neck pain on the same side she received her injection along with tightne...
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Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
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| 59 | 2021-01-13 | pain |
Tired; headache; achy; This is a spontaneous report from a contactable other healthcare professional...
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Tired; headache; achy; This is a spontaneous report from a contactable other healthcare professional (hcp). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL1283, expiry date not reported), intramuscular in the left arm on 07Jan2021 11:45 at a single dose for Covid-19 immunization. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination (not diagnosed with COVID-19). Concomitant medication included pantoprazole. The patient had the first dose of BNT162B2 (lot EK5730, expiry date reported) for Covid-19 immunization on 17Dec2020 16:00 at a single dose in the right arm intramuscularly. The patient had no other vaccine in four weeks. Both Covid-19 vaccinations were administered in the hospital. On 08Jan2021 12:00, the patient was tired, had headache, and was achy. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatment was received in response to the events reported. Since the vaccination (post vaccination), the patient has not been tested for COVID-19. The outcome of the events tired, headache, and achy was recovering.
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| 59 | 2021-01-14 | pain |
4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This ...
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4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This is a spontaneous report from a contactable other hcp. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, intramuscular on the left arm on 07Jan2021 17:45 at a SINGLE DOSE and intramuscular on the left arm on 17Dec2020 18:45 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included escitalopram oxalate (LEXAPRO). On 07Jan2021, it was reported that 4 hours after vaccine, there was soreness at injection site. 14 hours following vaccine, the patient experienced sudden onset of severe whole body chills and whole body aches lasting up to 18 hours. The outcome of the events was recovered. Information on the lot/ batch number has been requested.
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| 59 | 2021-01-14 | pain in extremity |
Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare ...
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Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) then received the second dose (lot number: EK 9231, expiration date: not reported) on 08Jan2021 13:45 both via an unspecified route of administration on the left arm at a single dose for COVID-19 immunization. Medical history included that the patient had allergies to medications, food, or other products such as Penicillin, Sulfa drug and pork. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), ergocalciferol (VIT D) and biotin (BIOTIN). On 08Jan2021 22:45, 9 hours after vaccine the patient experienced diarrhea, severe chills and sore arm. As treatment, patient received ibuprofen (ADVIL) and fluids. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number (first dose) has been requested.
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| 59 | 2021-01-14 | feeling hot |
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ...
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I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
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| 59 | 2021-01-14 | pain |
Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior...
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Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior head and neck ache, and chills.
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| 59 | 2021-01-14 | dizziness |
On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started...
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On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21.
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| 59 | 2021-01-14 | tremor, involuntary muscle movements |
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi...
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Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
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| 59 | 2021-01-14 | pain, pain in extremity | Severe arm pain; severe body aches and headache. Fever |
| 59 | 2021-01-14 | dizziness | Tachycardia Hypertension (198/120) - no he of hypertension Lightheadedness |
| 59 | 2021-01-14 | dizziness, lightheadedness |
Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie...
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Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie down on floor. Initial blood pressure reading approximately 5 minutes later was 92/54. Patient did not lose consciousness. Repeat blood pressure reading approximately 10 minutes after vaccine administration was 122/78 and patient reported feeling better. Patient was observed for an additional 20 minutes with improvement of symptoms.
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| 59 | 2021-01-14 | weakness, pain | chills slight fever headache fatigue body aches no energy exhaustion |
| 59 | 2021-01-14 | pain |
soreness at injection site and sharp headache pain over my right eye that radiated to the back of my...
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soreness at injection site and sharp headache pain over my right eye that radiated to the back of my head, both started the night of the injection and through the next day
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| 59 | 2021-01-15 | pain in extremity, pain |
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later ...
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Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night. Unable to do my daily workouts and yoga.
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| 59 | 2021-01-16 | pain |
About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night...
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About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night, had mild sweats and chills and moderately severe body pain, especially in legs and back. The next morning had no sense of taste or smell. Body pain and loss of taste improved over the day. ,
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| 59 | 2021-01-16 | tingling |
Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and n...
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Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and needles" 20minutes after vaccine admin and then began itching. Presents to observation unit with red rash, 3-4 hives across upper and mid-back. Endorses itching on scalp as well as trunk. No rash noted on hands, arms, or face. Benadryl given after pt consulted with Dr. mild relief of symptoms. MDs spoke extensively with patient. She was ok to go home after her spouse arrived to drive her.
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| 59 | 2021-01-16 | tingling, restlessness |
Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes s...
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Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes she started to feel a "pins and needles" sensation on her arms and head. Right after that, pt describes diffuse puritis on scalp, across upper and lower back. Itching continues down extremities while being observed. Red rash, 4-5 hives on upper and mid-back. She is visibly scratching her neck, head and back and appears restless because of the intense itching. Assessed by Dr (IM) and Dr(ID); 50mg po Benadryl ordered and given to pt. She endorses mild relief from symptoms.
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| 59 | 2021-01-16 | tingling |
left arm became red with rash that was raised like small pimples, I felt like something was prickin...
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left arm became red with rash that was raised like small pimples, I felt like something was pricking me from the inside out then felt a little uneasy and face was itching with a small hive on my right cheek. My arm became bright red, I took a 25 mg benadryl which subsided some of the redness. I finished my shift and drove home about 5 pm still felt like I had prickly heat I took another 25 mg benadryl slept. I was extremely tired the next day which I could not tell if it was from the vaccine or benadryl or both. I work in a doctors office .
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| 59 | 2021-01-17 | pain in extremity | I experienced soreness in my right arm at the injection site and a few days later it went away. |
| 59 | 2021-01-17 | pain in extremity |
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vo...
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On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
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| 59 | 2021-01-17 | pain in extremity |
Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning w...
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Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning with chills, low grade fever, mild nausea, a headache, and a very sore arm. By late morning I had a fever of 100.9 and a severe headache. Early afternoon fever went up to 102.1. At this time I took ibuprofen 400mg and sumaptriptan 100mg. Fever came down and heaeache lessened.
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| 59 | 2021-01-19 | weakness, tingling, dizziness |
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut...
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Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
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| 59 | 2021-01-19 | dizziness |
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ...
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Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
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| 59 | 2021-01-19 | pain | TEMPERATURE OF 100.7, BODY ACHES, EYES STINGING AND DRY, HEADACHE |
| 59 | 2021-01-20 | balance disorder, migraine |
I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my...
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I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.
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| 59 | 2021-01-20 | pain in extremity |
she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hur...
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she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-21 | pain, pain | DEVELOPED HEADACHE, BODY ACHE, AND FATIGUE LASTING 24 HOURS. |
| 59 | 2021-01-21 | pain | FEVER MAX 102,BODY AND JOINT ACHES,HEADACHE |
| 59 | 2021-01-21 | numbness, speech disorder, balance disorder, tingling |
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting...
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Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
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| 59 | 2021-01-21 | pain |
Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Sys...
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Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Vomiting-Mild
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| 59 | 2021-01-24 | pain |
Body aches (approximately 36-40 hours), low grade fever (under 100 degrees) & chills (approximately ...
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Body aches (approximately 36-40 hours), low grade fever (under 100 degrees) & chills (approximately 36-40 hours). This am feeling back to normal.
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| 59 | 2021-01-24 | tingling, numbness |
On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right ...
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On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right arm, all the way down to my finger tips. it lasted for 10-20 minutes then slowly improved. This also happened after the first shot but I didn't think much about it because it only lasted for 3-5 minutes was mild and it was mostly just tingling.
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| 59 | 2021-01-24 | pain | PAIN INJECTION SITE, HEADACHE, CHILLS,PAIN ON JOINTS, TIRED,FEVER BODY PAIN. SINTOMES FOR 3 DAYS. |
| 59 | 2021-01-24 | pain |
soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea ...
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soreness at injection site x 2 days, bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
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| 59 | 2021-01-25 | pain in extremity, weakness |
Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous...
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Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis and Raynaud's phenomenon. Concomitant medication included natalizumab (TYSABRI) from 30Dec2020. The patient previously took and experienced allergies with celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunisation. On 12Jan2021, the patient had achy legs. The patient was also weak and very tired that afternoon, with slight headache. She was much better on 13Jan2021. Her sore arm developed the day after vaccination after both injections lasted a day or two. No treatment was received for the adverse events. Clinical outcome of the events was recovered on Jan2021.
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| 59 | 2021-01-25 | pain |
Low grade fever; chills; body aches; fatigue; This is a spontaneous report from a contactable other ...
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Low grade fever; chills; body aches; fatigue; This is a spontaneous report from a contactable other health professional reporting for herself. A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK4176, expiry date: not reported), via an unspecified route of administration, on 11Jan2021 10:45 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included COVID. The patient was diagnosed with COVID prior to vaccination. Concomitant medications included unspecified medications; the patient received other medications in two weeks. The patient previously took aspirin and experienced allergies. On 12Jan2021 06:30 PM, the patient experienced low grade fever, chills, body aches and fatigue. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
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| 59 | 2021-01-25 | pain, tremor, dizziness |
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ...
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Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 59 | 2021-01-25 | pain |
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea...
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ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
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| 59 | 2021-01-25 | nerve pain |
nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare...
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nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration in the right arm on 08Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included ongoing ideopathic neuropathy and high cholesterol. Concomitant medications included duloxetine (DULOXETINE), acetylsalicylic acid (ASPIRIN BP), and simvastatin (ZOCOR). The patient experienced nerve pain which began in feet, arms and hands on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the event was not recovered.
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| 59 | 2021-01-26 | dizziness, numbness |
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20...
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1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
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| 59 | 2021-01-26 | migraine |
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down,...
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14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down, but has joint pain and dull headache.
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| 59 | 2021-01-26 | numbness |
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai...
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Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
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| 59 | 2021-01-26 | tingling |
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later i...
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My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
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| 59 | 2021-01-26 | tingling, numbness |
NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD T...
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NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD TIGHTNESS IN THE BACK OF THE THROAT
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| 59 | 2021-01-26 | weakness | Nausea, stomach cramps, fatigue, and weakness |
| 59 | 2021-01-26 | balance disorder, dizziness | Pt c/o SOB and feeling "woozy". Slightly off balance |
| 59 | 2021-01-26 | balance disorder, dizziness |
Pt c/o feeling "woozy" and SOB. A little unsteady on feet. VS WNL for pt/per stated. BG 102. Pt ...
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Pt c/o feeling "woozy" and SOB. A little unsteady on feet. VS WNL for pt/per stated. BG 102. Pt stated that this is low for her. Given OJ and Peanut butter with crackers. Recovered. Sat for a while and then went to cafeteria to eat. Had not eaten today
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| 59 | 2021-01-26 | pain |
Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, an...
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Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization. The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours. She is fine now. She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it. She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events. The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious Information on the lot/batch number has been requested.
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| 59 | 2021-01-26 | numbness, dizziness, tingling |
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al...
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Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
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| 59 | 2021-01-26 | pain, pain in extremity |
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest...
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Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-26 | feeling hot |
VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF M...
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VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF MY BODY FEELS IMMEDIATELY TIRED AND WARM AN HEAVYBP 126/78 HR 74 POX 99 RA, KEPT FOR ANOTHER 15 MIN TO MONITOR
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| 59 | 2021-01-26 | vertigo | Vertigo |
| 59 | 2021-01-26 | weakness, lethargy | nause, stomach cramps, fever blisters, lethargic, weakness |
| 59 | 2021-01-26 | migraine |
severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable ...
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severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.
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| 59 | 2021-01-27 | unresponsive to stimuli |
Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1...
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Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse.
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| 59 | 2021-01-28 | pain in extremity | Back Pain and Arm pain |
| 59 | 2021-01-28 | dizziness |
slightly light headed for over an hour; This is a spontaneous report from a contactable healthcare p...
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slightly light headed for over an hour; This is a spontaneous report from a contactable healthcare professional (patient herself). A 59-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (left arm), on 30Dec2020 12:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included estradiol; loratadine; paracetamol (TYLENOL); fish oil and; calcium. The patient previously took tetracycline, amoxicillin, sulfamethoxazole and trimethoprim (BACTRIM) and, erythromycin and experienced allergies to all these drugs. Immediately after receiving the first dose, the patient was slightly light headed for over an hour on 30Dec2020 12:00 PM. No treatment was received for the adverse event. The patient recovered from the event on 30Dec2020. The patient had no other vaccine in four weeks and had no Covid prior to vaccination. The patient had a Covid-19 nasal swab Covid-test post vaccination on 05Jan2021 with results of negative, on 11Jan2021 with results of negative and, on 18Jan2021 with results pending.
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| 59 | 2021-02-02 | unresponsive to stimuli, dizziness |
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati...
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45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
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| 59 | 2021-02-03 | balance disorder, migraine |
lost all sense of balance; developed very severe migraines; This is a spontaneous report from a cont...
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lost all sense of balance; developed very severe migraines; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 13:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypertension, Depression, PCN allergy, Topical Iodine allergy. The patient was not Pregnant at the time of vaccination. Concomitant medications included metoprolol, HCTZ, bupropion hydrochloride (WELLBUTRIN), methylphenidate hydrochloride (CONCERTA), omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately eight days after receiving the Pfizer Covid vaccine, the patient lost all sense of balance on 30Dec2020. She developed very severe migraines. She was hospitalized for four days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was on multiple doses of steroids. She was now starting IV I G infusions. Treatment received for the events included Relpax, steroids, IV Infusions. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Lab data included Nasal Swab: negative on 30Dec2020. The outcome of both events was not resolved.; Sender's Comments: Based on the available information causality between events lost all sense of balance and very severe migraines and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-02-06 | pain | Shoulder pain when rotating arm around |
| 59 | 2021-02-07 | tingling |
Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roo...
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Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later. No Shortness of Breath, Difficulty Breathing, or problems swallowing. Administered 50 mg Benadryl. Symptoms improved slightly, symptoms did not worsen. Observed for an additional 40 minutes. Went home with husband. Instructed to follow-up with 911 if symptoms worsened.
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| 59 | 2021-02-07 | dizziness |
Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry....
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Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
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| 59 | 2021-02-17 | nerve pain, facial paralysis, dizziness |
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu...
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Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
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| 59 | 2021-02-19 | dizziness |
On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations,...
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On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.
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| 59 | 2021-02-21 | pain | Body aches and congestion after vaccine |
| 59 | 2021-02-21 | pain | chills body aches fever last for 24 hours |
| 59 | 2021-02-22 | pain |
02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolv...
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02/13/2021 I developed mild side effects of pain at injection site & minor body aches, These resolved on 02/14/2021. 02/15/2021 I developed an altered sense of smell. I smell an medicinal or chemical smell. Husband does not smell this so it is not an environmental odor. Received a covid test on 02/22/2021 which was negative. The altered sense of smell is still persisting. Notified my doctor of it & she asked that I notify the CDC as it may be a potential side effect from covid vaccine.
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| 59 | 2021-02-22 | pain | Chills, fatigue, body aches, no appetite Treated with Advil |
| 59 | 2021-02-22 | pain in extremity |
With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very dee...
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With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours. I woke to drink water and use restroom only. On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone. My first shot I had a little soreness in my arm only.
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| 59 | 2021-02-23 | pain |
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushe...
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small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
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| 59 | 2021-02-23 | pain in extremity, pain |
soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest l...
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soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
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| 59 | 2021-02-24 | dizziness |
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ...
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Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
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| 59 | 2021-02-24 | weakness, pain |
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen...
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Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
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| 59 | 2021-02-28 | pain, pain in extremity |
Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from...
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Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-02-28 | pain, pain in extremity |
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o...
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nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
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| 59 | 2021-03-01 | pain |
felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her neckl...
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felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown. Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-01 | movement disorder, weakness |
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;...
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racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-03-03 | dizziness |
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ...
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her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
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| 59 | 2021-03-03 | numbness, tingling |
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ t...
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mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-03 | dizziness |
right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it wa...
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right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen; felt sick similar to a sinus infection/pressure in front of head, jaw, right ear/sinus pressure/pressure in nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure; dizzy on and off/Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus problems, allergy, allergy to cow's milk, TMJ (she had her wisdom teeth she was having issues on the right side; after they pulled it out she was fine), and wisdom teeth pulled out at the age of 57 or 58. Concomitant medication included ascorbic acid, biotin, folic acid, iron, manganese, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM FRUITY CHEWABLES). The patient previously took keflex and was allergic to it. The patient received her first dose of COVID-19 vaccine on 19Jan2021. She was okay from Tuesday to Thursday. On Friday (22Jan2021), the patient reported to have felt sick similar to a sinus infection, there were pressure in front of head, jaw, and right ear and was dizzy on and off for a long period. She had a sinus pressure/pressure in her nose and felt like she had a bad sinus infection in whole head. She is not saying she had a sinus infection, but that's what she experienced after receiving the shot. Her right ear was aching, head was ache, and jaw was also aching/throbbing on unspecified dates. The patient mentioned that she had swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen on 07Feb2021 but it went away today (08Feb2021). It was actually her neighbor that noticed the swelling and said it was on the bottom of lip chin area, it also felt hard when touching it. She called her primary care doctor following the events. At first, she did not want to provide these to her primary care, she did not have high blood pressure, high cholesterol or anything, but she did have bad sinuses. She took an antibiotic for sinus and pressure and her doctor told her that these could be side effects of the COVID vaccine as it causes dizziness and pressure. The dizziness must have been from the pressure since it was in her ear, cheek bones, and right ear was throbbing. It took her one month to come back to her normal self. The patient is scheduled to receive the next shot on 09Feb2021 and asked if she need to get the next shot or should she wait another week. The patient recovered from events "felt sick similar to a sinus infection/pressure in front of head, jaw, and right ear/sinus pressure/pressure in her nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure" and dizzy on and off/dizziness on 06Feb2021; recovered from event swelling of bottom lip on 08Feb2021; while unknown outcome for the remaining events. Information on the lot/batch number has been requested.
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| 59 | 2021-03-08 | weakness |
Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021...
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Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)
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| 59 | 2021-03-09 | numbness |
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ...
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having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
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| 59 | 2021-03-10 | dizziness, pain |
Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat ti...
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Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat tightness and reported having left shoulder pain for the prior 1.5 hours. patient was sent to the ED by EMS. The pt states that she had her first covid vaccine injection today and less than 30 minutes after her vaccine she developed acute central chest pain radiating to her left shoulder. She was given a full dose asa and 1 SL nitro by EMS. She states her chest pain was a 9/10 and it was pressure and tightness. She had associated lightheadedness. She states her pain is much worse than her typical chest pain she gets at home and takes nitro for. She states she is unsure if it is exertional, it is not worsened by deep breathing or palpation. She denies syncope, facial swelling, diaphoresis, n/v, abdominal pain, and hx of allergic reactions from vaccines.
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| 59 | 2021-03-16 | tingling, feeling cold, numbness |
I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting t...
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I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting the vaccine both my right hand and right leg started tingling and I had pins and needles sensation. I also woke up in the middle of the night with immense night sweating. My arm started becoming numb and cold. I talked to a doctor and she suggested I go to the ER right away as this could be indicative of a minor stroke. I was admitted in the hospital as they needed to run several tests. I spoke with other doctors who suggested not taking the 2nd shot as it could make matters worse. So I opted out of taking the 2nd jab. I wonder if there is any study about adverse reaction for former Covid positive people and if they are better of only taking the 1st jab. Another Covid positive friend also had a similar reaction after the 1st jab. His right side of face became numb. I am worried about lasting damage if any. Could somebody please get back with me on this.
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| 59 | 2021-03-18 | dizziness, pain |
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un...
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Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
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| 59 | 2021-03-18 | numbness |
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l...
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Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
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| 59 | 2021-03-22 | dizziness |
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM...
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Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
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| 59 | 2021-04-04 | pain in extremity |
Telephone call received from client who reports she received vaccine yesterday and is now having a ...
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Telephone call received from client who reports she received vaccine yesterday and is now having a sore arm and pressure in her ears. Also stated she had sinus infection for a month. Having buzzing in her ears but not sure if buzzing or "shot:. Stated at work at time of this report and just wanted to report.
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